Measurement probe with heat cycle event counter

ABSTRACT

A system comprising a measurement device and a handheld device is disclosed, the system adapted to withstand, detect, record, and display heat cycle event counts. The measurement device comprises a sensor for measuring and a heat cycle detection unit. The heat cycle detection unit comprises a temperature or pressure responsive element, a detection module, data interface, and data memory. The handheld device comprises a screen, a button, a communication circuit, and a processing system. The communication circuit is configured to communicate with the measurement device and a computing device and the processing system is configured to receive non-measurement information from the measurement device, display the received information on the screen, and cycle the received information displayed on the screen based on an actuation of the button, wherein the handheld device is used to display a heat sterilization cycle count of the measurement device.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/853,750, filed Sep. 14, 2015, which is a continuation-in-part of U.S.patent application Ser. No. 14/801,625, filed Jul. 16, 2015, which is acontinuation of U.S. patent application Ser. No. 14/207,347, filed Mar.12, 2014, granted as U.S. Pat. No. 9,117,166, on Aug. 25, 2015, whichclaims priority benefit of U.S. Provisional Patent Application No.61/794,355, filed Mar. 15, 2013; U.S. patent application Ser. No.14/853,750, filed on Sep. 14, 2015, is a continuation-in-part of PatentCooperation Treaty Application No. PCT/US2014/025025, filed Mar. 12,2014, which claims priority benefit of U.S. Provisional Application No.61/794,355, filed Mar. 15, 2013; each of the aforementioned applicationsare incorporated by reference in its entirety herein.

BACKGROUND

Field of the Invention

The present invention relates to measurement probes. More particularly,the invention relates to devices and methods used to detect and countheat cycles experienced by measurement probes.

Description of the Related Art

Control of industrial processes is largely dependent on measurementsignals received from measurement devices within process mediums.Measurement probes, which are equipped with sensors such as pH sensors,temperature sensors, redox sensors, carbon dioxide sensors, anddissolved oxygen sensors, are frequently used to monitor biological andchemical processes in the fields of biotechnology, pharmaceuticals, andfood/beverage processing. In such industries, accuracy of measurementsis critical.

In such industries, sterilization or cleaning is also critical. Frequentsterilization or cleaning is often required in these industries. Thismay be because bacteria and other microorganisms may proliferate onunsterilized surfaces and create health risks. Alternatively,sterilization may help avoid introducing contaminants of competingmicroorganisms into a cell culture. Additionally, sterilization orcleaning of bioprocess vessels or pipes in which sensors are installedcan expose the sensors to high temperatures and/or harsh chemicals thatcan introduce errors in the sensor's measurement signal or even lead tosensor failure.

Three sterilization or cleaning methods are frequently employed tosterilize equipment used in biological or chemical processes:steam-in-place sterilization, clean-in-place, and autoclaving.Steam-in-place sterilization procedures allow for in-line pressurizedsteam sterilization of all surfaces located within the interior of areaction vessel or other processing container (herein referred to as aprocessing vessel), thus providing for sterilization withoutdisassembly. Clean-in-place procedures allow for in-line cleaning byflushing the process vessel and associated piping with sanitizingchemical solutions at elevated temperatures. Autoclaving involvessubjecting the processing vessel and the entire probe, to pressurizedsteam heat within a separate autoclave chamber. Autoclaving is often apreferred method of sterilization at least in part when the processingvessel is relatively small and transportable to the autoclave chamber.The major drawback to autoclaving is that the entire probe body issubjected to the high sterilization temperature and this can have adetrimental effect on any internal circuitry that is powered up at thetime. If the probe is externally powered then it must be disconnectedfrom its signal and/or power cable before it is placed in the autoclave.In many industries, subjecting the process vessel, probes, andassociated equipment to high pressure steam at 121° C. in an autoclavefor 20-30 minutes is sufficient to achieve sterilization. However, it isnot uncommon to find that the vessel, probes, and associated equipmentare exposed to pressurized steam at temperatures in excess of 130° C.and for periods of 60 minutes or longer to ensure completesterilization.

Measurement probes can experience structural changes, aging, anddecreased functionality and accuracy through exposure to extremeconditions. Particularly, the rapid increase and decrease of temperatureassociated with common steam heat sterilization or hot chemical solutioncleaning methods may lead to probe degradation; thus, measurement probesare consumable products which must be replaced regularly. In industry, abalance is required when determining how frequently to replacemeasurement probes. Premature exchange of probes unnecessarily increasescosts, whereas a probe that has reached the end of its life may failduring use. Loss of the probe measurement in mid-process often resultsin loss of process control and the subsequent ruin of an entirebiological or chemical batch, leading to costly waste and delays.Accordingly, it is important for the probe operator to monitor thecondition and evaluate the fitness for service of industrial measurementprobes by tracking the number of heat cycles that it has experienced.

Additionally, the high temperatures a measurement probe may endureduring a clean-in-place, steam-in-place, or autoclave operation maycause damage to the measurement probe or to its operation. While thehigh heat of the sanitizing operation may not physically affect theprobe, operation at high heat may result in unexpected outcomes. Thus,in an embodiment, the measurement probe and the associated circuitryitself may be protected from high temperatures so as to protect thecircuitry and the physical structure of the device. In anotherembodiment, the measurement probe and the associated circuitry may beprotected from operating in high temperatures so as to avoid unexpectedoperations and outcomes and to avoid the possibility of errors infunctionality and operation that may result from operating themeasurement probe and associated circuitry at high temperatures.

SUMMARY

The present disclosure describes devices and methods used to detect andcount heat cycles experienced by measurement probes, particularly heatcycles associated with steam heat sterilization and hot chemicalsolution cleaning procedures. These procedures are among the greatestcontributors to probe degradation and failure. Accordingly, by providingmeans for detecting and maintaining a count of the heat cyclesassociated with these procedures, the devices and methods describedherein will help probe operators determine the risk associated withcontinued use of the probe and determine when it is time to replace themeasurement probes.

The embodiments disclosed herein each have several innovative aspects,no single one of which is solely responsible for the desirableattributes of the invention. Without limiting the scope, as expressed bythe claims that follow, the more prominent features will be brieflydisclosed here. After considering this discussion, one will understandhow the features of the various embodiments provide several advantagesover current measurement probes.

One aspect of the disclosure is an apparatus adapted to couple to ameasurement device and display information acquired from the measurementdevice. The apparatus comprises a screen, a button, a connectorconfigured to connect to the measurement device, a power sourceconnector, a processing system, and a computing device connector. Theprocessing system is configured to receive information from themeasurement device, display the received information on the screen, andcycle the received information displayed on the screen based on anactuation of the button. The computing device connector is configured toelectrically and physically couple the apparatus to a computing device.

In some embodiments, the power source comprises a battery configured toprovide electrical power to the screen, the processing system, and themeasurement device to allow the processing system to receive informationfrom the measurement devices and display the received information on thescreen. In some embodiments, the apparatus further comprises a memoryconfigured to store the information received from the measurement deviceand information entered by a user via the button or the computing devicecoupled via the connector. In some embodiments, the information receivedfrom the measurement device comprises one or more of an identificationinformation of the measurement device, a sterilization cycle count ofthe measurement device, a location of installation of the measurementdevice, one or more calibration parameters of the measurement device,one or more manufacturing data of the measurement device, and customerspecific information of the measurement device.

In some embodiments, the one or more manufacturing data comprises aserial number, a manufacturer part number, performance data, and a dateof calibration and performance tests, and the customer specificinformation comprises an experiment name with which the measurementdevice is associated, an operator's name with which the measurementdevice is associated, a lot number with which the measurement device isassociated, and one or more customer defined fields. In someembodiments, the information received from the measurement devicefurther comprises data measured by the measurement device.

Another aspect of the disclosure is a system. The system comprises ameasurement device adapted to withstand and automatically count a heatsterilization or cleaning cycle and a handheld device. The handhelddevice comprises a screen, a button, a connector configured to couplethe handheld device to a computing device, and a processing system. Theprocessing system is configured to receive information from themeasurement device, display the received information on the screen, andcycle the received information displayed on the screen based on anactuation of the button. The handheld device is used to display a heatsterilization cycle count of the measurement device connected to thehandheld device.

In some embodiments, the computing device may be coupled to the handhelddevice and configured to perform at least one of calibrating themeasurement device via the handheld device, viewing information storedin the measurement device via the handheld device, editing informationstored in the measurement device via the handheld device, viewinginformation stored in the handheld device, and editing informationstored in the handheld device. In some embodiments, the handheld deviceis further used to display one or more of calibration parameters of themeasurement device, manufacturing data of the measurement device, andcustomer custom fields of the measurement device.

One aspect of the disclosure is a system comprising a measurement deviceand a handheld device or an apparatus comprising the measurement device.The handheld device comprises a screen, a button, a connector configuredto couple with the measurement device, a connector configured toelectrically and physically couple the handheld device to a computingdevice, and a processing system. The processing system is configured toreceive information from the measurement device, display the receivedinformation on the screen, and cycle the received information displayedon the screen based on an actuation of the button. The handheld deviceis used to display a heat sterilization cycle count of the measurementdevice connected to the handheld device. The measurement device isadapted to withstand and automatically detect a heat sterilization orcleaning cycle and increment and maintain a counter of the total numberof cycles for later review by the operator, particularly when themeasurement device is disconnected from all external power sources. Themeasurement device includes a measurement probe including a sensorconfigured to detect a characteristic of a medium and generate ameasurement signal; a condition responsive element including either atemperature responsive element or a pressure responsive element; and aheat cycle detection unit including a detection module, a datainterface, and a data memory. The detection module is configured todetect a heat cycle event using the condition responsive element, andrecord detection of the heat cycle event in the data memory. In someembodiments the heat cycle event is part of an autoclave procedure, asteam-in-place sterilization procedure, or a clean-in-place procedure.In some embodiments the measurement device is configured toautomatically power up the heat cycle detection unit as soon as the heatcycle is detected, the heat cycle detection unit then increments acounter, and then the measurement device powers itself off to protectthe circuit from prolonged and excessive heat exposure as in the case ofan autoclave procedure where the entire probe is autoclaved. In someother embodiments the measurement device will automatically turn itselfback on when the heat cycle is complete and the measurement device hascooled off to a safe operating temperature. In some embodiments, themeasurement device will automatically turn itself back on when the heatcycle is complete and the device has cooled off to a safe operatingtemperature, at which point the measurement device records theoccurrence of the heat cycle, and then the measurement deviceautomatically powers off until the next heat cycle is detected. In otherembodiments the measurement device will remain off to conserve batterypower and only turn itself back on briefly when another heat cycle isdetected and the cycle needs to be counted by the heat cycle detectionunit. In some embodiments, the measurement probe and the heat cycledetection unit are separably connected. In other embodiments, themeasurement probe and the heat cycle detection unit are fixedlyintegrated.

In some embodiments, the condition responsive element is a first switchconfigured to transition from a first state to a second state when thefirst switch exceeds a first temperature or a first pressure. In suchembodiments, the detection module is configured to record detection of aheat cycle event in the data memory in response to the first switchtransitioning from the first state to the second state. The measurementdevice may further include a capacitor coupled to the first switch,which is configured to discharge in response to the first switchtransitioning from the first state to the second state. In suchembodiments, the detection module need not be powered up during anautoclave cycle but is configured to detect the discharged capacitor andrecord detection of a heat cycle event in the data memory after theautoclave detection unit is powered back on following an autoclavecycle. The first switch changes to its second state at some pre-definedtemperature that marks the beginning of the heat cycle. This secondstate discharges a capacitor. When the detection module powers back upit detects the discharged capacitor and increments the event counter.

In some embodiments, the measurement device also includes a portablepower source in addition to, or instead of, a capacitor. In suchembodiments, the detection module is configured to record detection of aheat cycle event in the data memory in response to a temperatureresponsive element exceeding a first temperature or a pressureresponsive element exceeding a first pressure. After the counter isincremented the autoclave detection unit is configured to power off inresponse to the temperature responsive element exceeding the firsttemperature or in response to the pressure responsive element exceedingthe first pressure. In some such embodiments, the measurement deviceincludes a second switch configured to transition from a power-off stateto a power-on state when the second switch falls below a power-ontemperature or a power-on pressure. In such embodiments, the autoclavedetection unit is configured to automatically power on when the secondswitch transitions from the power-off state to the power-on state. Insome embodiments, the second switch and the condition responsive elementare one and the same; a universal switch can acts as both the secondswitch and the condition responsive element.

The first switch and/or the second switch in various embodiments may beselected from the group consisting of: a bimetallic strip, an integratedthermal switch, and a pressure switch. The condition responsive elementof other embodiments may be selected from the group consisting of: aresistance temperature detector, a bimetallic strip, an integratedthermal switch, a positive temperature coefficient thermistor, switchingPCT thermistor, or other thermistor, a pressure switch, a reed switch, apiezoelectric pressure sensor, an electromagnetic pressure sensor, acapacitive pressure sensor, and a piezoresistive strain gauge. Invarious embodiments, the first temperature and/or power-on temperatureare within a range of 50 to 120 degrees Celsius, and the first pressureand/or power-on pressure are within a range of 15 to 45 psi.

In some embodiments, the measurement device also includes a couplingelement configured to engage with a vessel body such that, when thecoupling element is engaged with the vessel body, the measurement deviceincludes a distal portion that is positioned within a vessel cavity anda proximal portion that is positioned external to the vessel cavity. Insome such embodiments, the condition responsive element is a distalcondition responsive element, preferably positioned in or on the distalportion. In other embodiments, the condition responsive element is aproximal condition responsive element, preferably positioned in or onthe proximal portion. When the measurement device comprises a proximalcondition responsive element, the measurement device may additionallyinclude a distal condition responsive element, preferably positioned inor on the distal portion. In such embodiments, the detection module isconfigured to detect a heat cycle event and record detection of the heatcycle event in the data memory in response to either the proximalcondition responsive element exceeding a first temperature or pressureor the distal condition responsive element exceeding a vesselsterilization temperature or pressure. Additionally, in suchembodiments, the detection module may be configured to detect anautoclave cycle and record detection of the autoclave cycle in the datamemory in response to the proximal condition responsive elementexceeding a first temperature or pressure, and the module may be furtherconfigured to detect a steam-in-place cycle and record detection of thesteam-in-place cycle in the data memory in response to only the distalcondition responsive element exceeding the vessel sterilizationtemperature or pressure. The autoclave detection unit can be configuredto power off when an autoclave cycle is detected and optionally poweroff when a steam-in-place cycle is detected.

In some embodiments both a distal condition responsive element and atemperature responsive element located in the distal portion of themeasurement device and another proximal condition responsive element.When a preset temperature limit is exceeded in the sterilization orcleaning procedure in the distal portion of the measurement device, thedistal condition responsive element changes state and powers on thecircuit in the detector module. The module then increments the heatcycle counter and additionally uses the temperature responsive elementin the distal portion to measure additional information such as maximumheat exposure and length of exposure time in the case of steam-in-placeor clean-in-place procedures. The proximal temperature responsiveelement is also powered on and it monitors the measurement devicetemperature at the proximal portion. If the proximal temperature exceedsa preset limit then the measurement device logic determines that themeasurement device is being autoclaved and the circuit completely shutsdown after incrementing the heat cycle counter.

In some embodiments, the measurement device also includes a pH sensorpositioned in the distal portion. In one such embodiment, a distalcondition responsive element, preferably, but not necessarily, locatedin the distal portion, can change state due to a process heat cycle andswitch on the measurement device's power and the detection module can beconfigured to differentiate and detect a clean-in-place cycle and recorddetection of the clean-in-place cycle when a distal condition responsiveelement exceeds a clean-in-place temperature or pressure and ameasurement from the pH sensor exceeds a clean-in-place pH level, bothwithin a defined period of time. The distal condition responsive elementof some embodiments is a temperature responsive element. In at leastsome embodiments, the clean-in-place temperature is within a range of 65to 95 degrees Celsius, and the clean-in-place pH is within the extremeranges of either 9 to 14 pH or 1 to 4 pH.

In various embodiments, the first temperature and/or the vesseltemperature are within a range of 50 to 120 degrees Celsius, and thefirst pressure is within a range of 15 to 45 psi. The measurement probeis selected from the group consisting of an amperometric, apotentiometric, an optical, a capacitive, and a conductive probe.Additionally, in some embodiments, the sensor is selected from the groupconsisting of a pH sensor, a temperature sensor, a dissolved oxygensensor, and a combination thereof. The detection module of someembodiments is selected from the group consisting of a circuit, amicroprocessor, a Digital Signal Processor, an Application SpecificIntegrated Circuit, and a Field Programmable Gate Array. The datainterface of some embodiments is selected from the group consisting of awireless transmitter, an input/output terminal, a data bus, galvanicmetal connector contacts, a contactless inductive coupling interface(see e.g. DE 19540854A1, DE 4344071A1, and U.S. Pat. Nos. 8,639,467,7,785,151, 6,705,898, 6,476,520, 5,325,046, and 5,293,400; each of whichis incorporated herein by reference in its entirety and for disclosurethereof), and an industry standard 8 pin connector. In some embodiments,the measurement device also includes a power-gathering system, such as,for example, a photodiode or a photovoltaic cell. In some embodiments,the data interface and/or the data output may allow for communication ofsignals and data via a secondary (or relay) device, as will be discussedin further detail below.

An additional aspect of the disclosure is a method of automaticallycounting autoclave and other heat sterilization cycles and/or cleaningcycles experienced by any embodiment of the measurement device describedabove, while protecting the circuitry contained within the measurementdevice and managing the measurement device's power supply. The methodincludes detecting a heat sterilization cycle using a first temperatureresponsive element that is configured to respond when the temperatureexceeds a first temperature, automatically powering up the detectionunit circuitry if off, recording detection of the heat sterilizationcycle in a data memory and incrementing a counter, and automaticallypowering off the detection unit circuitry after detection of the heatsterilization cycle, if it is desired in a particular process procedureto protect the measurement device's circuit from malfunctioning due toexcessive heat during the heat cycle and to conserve the measurementdevice's power.

Another aspect of the disclosure is a method of automatically counting aheat cycle experienced by a measurement device. The method includesproviding a measurement device, the measurement device including ameasurement probe having a sensor configured to detect a characteristicof a medium and generate a measurement signal, a condition responsiveelement, and a heat cycle detection unit having a detection module, adata interface, and a data memory. The method further includes detectinga heat cycle event, using the condition responsive element and recordingdetection of the heat cycle event in the data memory. In someembodiments, the heat cycle event is an autoclave cycle, asteam-in-place sterilization event, or a clean-in-place event. In someembodiments, the measurement device is configured to automatically powerup the heat cycle detection unit after detection of the heat cycle eventand then, after incrementing the counter, power it down if the heatcycle event comprises an autoclave cycle.

In some embodiments of the method, the condition responsive element is afirst switch that transitions from a first state to a second state whenthe first switch exceeds a first temperature or a first pressure, andthe detection module records detection of a heat cycle event in the datamemory in response to the first switch transitioning from the firststate to the second state. In some such embodiments, the method alsoincludes discharging a capacitor coupled to the first switch in responseto the first switch transitioning from the first state to the secondstate. In such embodiments, detecting a heat cycle event using thecondition responsive element involves detecting a discharged capacitor.In some such embodiments, detecting a discharged capacitor and recordingdetection of a heat cycle event in the data memory occur after theautoclave detection unit is powered on following an autoclave cycle.

In some embodiments of the method, the autoclave detection unit receivespower from a portable power source electrically coupled to themeasurement device. The detection module of some such embodimentsrecords detection of a heat cycle event in the data memory in responseto the condition responsive element exceeding a first temperature or afirst pressure. The autoclave detection unit of some such embodimentspowers off in response to the condition responsive element exceeding thefirst temperature or the first pressure. In some embodiments, the methodadditionally includes automatically powering on the autoclave detectionunit when a second switch in the measurement device transitions from apower-off state to a power-on state. In such embodiments, the secondswitch transitions from the power-off state to the power-on state whenthe second switch falls below a power-on temperature or pressure. Insome embodiments, a universal switch within the measurement deviceincludes both the second switch and the condition responsive element.

In various embodiments of the method, the first temperature and/or thepower-on temperature are within a range of 50 to 120 degrees Celsius,and the first pressure and/or the power-on pressure are within a rangeof 15 to 45 psi.

The method of some embodiments also includes engaging with a vessel bodysuch that a distal portion of the measurement device is positionedwithin a vessel cavity and a proximal portion of the measurement deviceis positioned external to the vessel cavity. In some such embodiments,the condition responsive element is positioned in or on the distalportion. In other embodiments, the condition responsive element ispositioned in or on the proximal portion.

In some embodiments having a proximal condition responsive element,preferably positioned in or on the proximal portion, the detectionmodule detects a heat cycle event and records detection of the heatcycle event in the data memory in response to either the proximalcondition responsive element exceeding a first temperature or firstpressure or a distal condition responsive element, preferably positionedin or on the distal portion, exceeding a vessel sterilizationtemperature or pressure. In some such embodiments, the step of detectinga heat cycle event and recording detection of the heat cycle event inthe data memory includes one of: detecting an autoclave cycle andrecording detection of the autoclave cycle in the data memory inresponse to the proximal condition responsive element exceeding a firsttemperature or a first pressure, or detecting a steam-in-place cycle andrecording detection of the steam-in-place cycle in the data memory inresponse to the distal condition responsive element exceeding the vesselsterilization temperature or pressure and the proximal conditionresponsive element not exceeding a first temperature or a firstpressure. In some such embodiments, the autoclave detection unit powersoff when an autoclave cycle is detected and optionally powers off when asteam-in-place cycle is detected.

In the method of some embodiments, the detection module detects aclean-in-place cycle and records detection of the clean-in-place cyclewhen: (1) a distal condition responsive element, preferably located inor on the distal portion exceeds a clean-in-place temperature orpressure, and (2) a measurement from a pH sensor positioned in thedistal portion exceeds a clean-in-place pH level, both within a definedperiod of time. In some such embodiments, the distal conditionresponsive element, preferably located in or on the distal portion, is atemperature responsive element.

In some embodiments of the method, the clean-in-place temperature iswithin a range of 65 to 90 degrees Celsius and/or the clean-in-place pHis within a range of either 9 to 14 pH or 1 to 4 pH. Additionally oralternatively, in some embodiments, the first temperature and the vesseltemperature are within a range of 50 to 120 degrees Celsius and thefirst pressure is within a range of 15 to 45 psi. In any of theembodiments disclosed herein, the data interface may be selected fromthe group consisting of a wireless transmitter, an input/outputterminal, a data bus, and an industry standard 8 pin connector. In anyof the embodiments disclosed herein, the measurement device may furthercomprise an inductive or wireless coupling connector, wherein theinductive or wireless coupling connector is configured to permittransfer of wherein at least one of energy, power, and data aretransferred via optical, inductive or wireless coupling between themeasurement device and at least one of an external power supply ortransmitter, optionally via a relay device. In any of the embodimentsdisclosed herein, at least one of an energy, a power, and a data may betransferred via optical, inductive or wireless coupling between themeasurement device and at least one of an external power supply ortransmitter, optionally via a relay device.

Another aspect provides a system comprising a measurement device and ahandheld device. The measurement device is adapted to withstand andautomatically count a heat sterilization or cleaning cycle. Themeasurement device comprises a measurement probe, a condition responsiveelement, and a heat cycle detection unit. The measurement probecomprises a sensor configured to detect a characteristic of a medium andgenerate a measurement signal. The condition responsive elementcomprises either a temperature responsive element or a pressureresponsive element. The heat cycle detection unit comprises a detectionmodule, a data interface, and a data memory and is configured to detecta heat cycle event using the condition responsive element and recorddetection of the heat cycle event in the data memory. The measurementdevice is configured to automatically power off the heat cycle detectionunit after detection of the heat cycle. The handheld device is connectedto the measurement device and comprises a screen, a button, acommunication circuit configured to communicate with the measurementdevice and a computing device, and a processing system. The processingsystem is configured to receive non-measurement information from themeasurement device, display the received information on the screen, andcycle the received information displayed on the screen based on anactuation of the button. The handheld device is used to display a heatsterilization cycle count of the measurement device.

An additional aspect provides a method for automatically counting anddisplaying a heat cycle experienced by a measurement device. The methodcomprises providing a measurement device. The measurement devicecomprises a measurement probe having a sensor configured to detect acharacteristic of a medium and generate a measurement signal, acondition responsive element, and a heat cycle detection unit having adetection module, a data interface, and a data memory. The methodfurther comprises detecting a heat cycle event, using the conditionresponsive element, recording detection of the heat cycle event in thedata memory, connecting to and communicating with a handheld device, anddisplaying information communicated from the measurement device to thehandheld device on a screen of the handheld device. The informationdisplayed on the handheld device comprises a heat sterilization cyclecount of the measurement device.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned aspects, as well as other features, aspects, andadvantages of the present technology will now be described in connectionwith various embodiments, with reference to the accompanying drawings.The illustrated embodiments, however, are merely examples and are notintended to be limiting. Throughout the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. Note that the relative dimensions of the following figuresmay not be drawn to scale.

FIG. 1 depicts a perspective view of one embodiment of a measurementdevice.

FIG. 2 depicts a block diagram of one embodiment of a measurementdevice.

FIG. 3A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 3B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 3A.

FIG. 4A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 4B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 4A.

FIG. 5A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 5B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 5A.

FIG. 6A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 6B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 6A.

FIG. 7A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 7B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 7A.

FIG. 8 depicts a block diagram of another embodiment of a measurementdevice.

FIG. 9 depicts a block diagram of another embodiment of a measurementdevice.

FIG. 10 depicts a circuit diagram for an embodiment of a heat cycledetection unit.

FIG. 11 depicts a schematic circuit diagram for an embodiment of a heatcycle detection unit.

FIG. 12A depicts a block diagram of another embodiment of a measurementdevice.

FIG. 12B is a flowchart illustrating one method of operations performedby the measurement device of FIG. 12A.

FIG. 13 depicts a diagram of an embodiment of a handheld device that maycouple with a measurement device.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings, which form a part of the present disclosure. Theillustrative embodiments described in the detailed description,drawings, and claims are not meant to be limiting. Other embodiments maybe utilized, and other changes may be made, without departing from thespirit or scope of the subject matter presented here. It will be readilyunderstood that the aspects of the present disclosure, as generallydescribed herein, and illustrated in the Figures, can be arranged,substituted, combined, and designed in a wide variety of differentconfigurations, all of which are explicitly contemplated and form partof this disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.It will be understood by those within the art that if a specific numberof a claim element is intended, such intent will be explicitly recitedin the claim, and in the absence of such recitation, no such intent ispresent. For example, as used herein, the singular forms “a”, “an” and“the” are intended to include the plural forms as well, unless thecontext clearly indicates otherwise. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items. It will be further understood that the terms “comprises,”“comprising,” “includes,” and “including,” when used in thisspecification, specify the presence of stated features, integers, steps,operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, integers, steps,operations, elements, components, and/or groups thereof. Expressionssuch as “at least one of,” when preceding a list of elements, modify theentire list of elements and do not modify the individual elements of thelist.

To assist in the description of the devices and methods describedherein, some relational and directional terms are used. “Connected” and“coupled,” and variations thereof, as used herein include directconnections, such as being contiguously formed with or attached directlyto, on, within, etc. another element, as well as indirect connectionswhere one or more elements are disposed between the connected elements.“Connected” and “coupled” may refer to a permanent or non-permanent(i.e., removable) connection. “Connected” and “coupled” may refer toboth wired and wireless connections, for example, a wireless connectionor coupling may include a connection or coupling allowing for wirelesspower transfer and/or wireless communication.

“Secured” and variations thereof as used herein include methods by whichan element is directly fastened to another element, such as being glued,screwed or otherwise affixed directly to, on, within, etc. anotherelement, as well as indirect means of attaching two elements togetherwhere one or more elements are disposed between the secured elements.

“Proximal” and “distal” are relational terms used herein to describeposition. For clarity purposes only, in this disclosure, position isviewed from the perspective of an individual operating a measurementdevice positioned partially within a processing vessel. The portion ofthe measurement device located external to the vessel is viewed as beingclosest, and therefore, most proximal to the operator. The portion ofthe device positioned within the container is more distally located.

As used herein, “proximal condition responsive element,” “distalcondition responsive element,” “proximal temperature responsiveelement,” “distal temperature responsive element,” “proximal pressureresponsive element,” and “distal pressure responsive element,” and theirequivalents are used to describe the locations to which the condition,temperature or pressure responsive element are responsive, and notnecessarily where the element is located. For example, a distalcondition responsive element is responsive to conditions occurring at/inthe distal portion of a probe, and can be located in the distal portionof the probe, or can be located in the proximal portion of the probe butconfigured to be responsive to conditions at/in the distal portion ofthe probe. As a non-limiting example, a pressure sensing element locatedin the proximal portion of the probe could be in fluid communicationwith the interior of the distal portion of the probe, such that changesin pressure in the distal portion of the probe are sensed by thepressure sensor located in the proximal portion of the probe—such apressure sensor is “distal condition responsive element” or “distalpressure responsive element” because it is responsive to conditionsin/at the distal portion of the probe. In another example, a proximalcondition responsive element is responsive to conditions occurring inthe proximal portion of the measurement probe, but could be located inthe proximal portion, the distal portion, or outside the measurementprobe.

The terms “automatically” or “autonomously” as used herein are intendedto identify devices capable of taking an action without external inputfrom a user or other device. As a non-limiting example, such an actionincludes turning on and/or turning off a portion or all of the device.An energy or power autonomous device may be capable of managing itsenergy or power free from external connections. For example, an energyor power autonomous device may comprise a photovoltaic cell or abattery. In one example, a device may activate on demand by waking up orpowering on based upon sensed conditions to perform a task and going tosleep or powering off after the task is complete without externalcommands.

Various sensors or switches may be utilized in the invention asdescribed herein. These sensors and switches may detect variousconditions that a measurement probe may face during operation andmaintenance. In some embodiments, these sensors and switches may monitortemperature. In another embodiment, these sensors and switches maymonitor pressures. In some other embodiments, these sensors and switchesmay monitor a combination of temperature and/or pressure. Sensors andswitches that may monitor pressure may be configured so as to monitoratmospheric pressure or internal pressure of the measurement probe. Asensor or switch that monitors atmospheric pressure may be intended tomeasure the pressure of the environment outside the measurement probe. Asensor or switch that monitors internal pressure may be intended tomeasure the pressure internal to the measurement probe. A sensor or aswitch that monitors internal pressure may be used to detect atemperature change where the measurement probe is sealed, such that atemperature change of the measurement probe creates a pressure changeinternal to the measurement probe that may be detected by the internalpressure sensor or switch.

In some embodiments, a pressure condition responsive element (pressuresensor or switch) may be configured to respond to pressure conditionchanges within the proximal portion of the measurement probe, whereinthe pressure within the proximal portion is isolated from the pressurewithin the distal portion. In such an embodiment, the pressure conditionresponsive element may be configured to respond to either internalpressure changes or atmospheric pressure changes. Such a pressure changeof the proximal portion may indicate the measurement probe isexperiencing an autoclave cycle. In another embodiment, a pressurecondition responsive element may be configured to respond to pressurechanges within the distal portion of the measurement probe, wherein thepressure within the proximal portion is isolated from the pressurewithin distal portion. In such an embodiment, the pressure conditionresponsive element may be configured to respond to internal pressurechanges. Such pressure changes of the distal portion may indicate themeasurement probe is experiencing any heat cycle involving elevatedtemperatures or pressures but may not allow for the distinguishingbetween an autoclave cycle and a clean-in-place or steam-in-place cycle.

There is a need for a measurement probe that monitors and quantifies itsown usage and operational fitness in the bioprocess industries. Aleading cause of probe degradation in bioprocess applications is thethermo shock associated with the increase and decrease of temperatureassociated with some heat sterilization procedures that utilizepressurized steam and cleaning procedures that utilize hot sanitizingchemical solutions. A bioprocess industry standard for keeping track ofwear on a measurement probe is the number of these heat cyclesexperienced by the probe. In some applications, probes are exposed to nomore than two to ten heat cycles before being retired. In otherapplications, the count may be higher. The particular number of heatsterilization or cleaning cycles that a probe can withstand varies byprobe manufacturer, sterilization or cleaning method, operatormaintenance, and the environmental conditions within the processingmedium; thus, probe operators familiar with their unique uses andprocesses are best equipped to predict the lifespans of their respectiveprobes. Currently, however, in bioprocess laboratory and productionsettings, it is often easy to lose track of the number of heatsterilization or cleaning cycles experienced by each probe.

Accordingly, there is more than one probe design currently on the marketthat is configured to detect and record steam-in-place sterilizationcycles. However, the design of such probes renders them inoperableduring autoclave cycles. In the current models, the probes must beunplugged and fully powered down before being placed in an autoclavechamber; as a result, they can neither detect nor count autoclavecycles. Without being able to automatically detect and count this widelyused sterilization method, in many bioprocess applications the currentgeneration of sterilization-counting probes provides little benefit overconventional probe designs. In addition, probes are often disconnectedfrom external power sources during steam-in-place cycles to avoiddamaging cables which may come in contact with steam supply pipes or thehot vessel wall. Probes which require an external power source to detectand record steam-in-place cycles will not record the steam-in-placeevent if the operator disconnects the probe cables.

Another existing probe design uses recorded temperature andtime-at-temperature data to self-calculate the length of its remaininglifespan. However, these calculations can provide probe lifespanestimates that are not particularly accurate for the application athand. This can lead the process operator into a false sense of safety ashe reuses a probe that self-predicts that it has ample lifespanremaining and then the probe fails. Lifespans vary across industries andcompanies and are dependent on nearly innumerable factors. Additionally,the cost of probe failure, and thus, the willingness to accept risk ofprobe failure, varies across companies.

Various embodiments disclosed herein may overcome some or all of thedeficiencies mentioned above. The embodiments relate to devices andmethods used to monitor and quantify the usage and operational fitnessof measurement probes by automatically (without user input) countingheat cycle events experienced by said probes, even when disconnectedfrom external power supplies. The measurement devices of variousembodiments are each configured to detect exposure to heat sterilizationor hot chemical cleaning cycles, including autoclave cycles,steam-in-place cycles and/or clean-in-place cycles, and subsequentlymaintain an accurate count of the sterilization or cleaning cyclesexperienced. With such an accurate count, laboratory technicians andother probe operators may be able to easily and efficiently determinewhen it is time to order new probes and/or throw away existing probesbased on their own unique experience with that particular bioprocessapplication. There is currently no commercial probe in the bioprocessindustries that can automatically count and record to memory the numberof autoclave cycles that it has experienced. The preferred embodimentsdisclosed herein provide an accurate count of the heat cycles completelyautomatically and with no operator input or assistance. It is completelyautomated. These preferred devices also improve the accuracy of the heatcycle count for probes undergoing steam-in-place and clean-in-placeprocedures. These devices enable accurate heat cycles counts for probeseven when not connected to associated instrumentation for any heat cycleprocedure.

A measurement device representative of the various embodiments discussedin more detail below includes at least a measurement probe, a conditionresponsive element, and a heat cycle detection unit. The measurementprobe may include a sensor configured to detect a characteristic of amedium and generate an electrical signal or a measurement signalrepresenting a measured value relating to the characteristic, typicallyan analog or digital signal. The sensor can be any electrochemicalsensor known to those skilled in the art. For example, in someembodiments, the sensor may be a pH sensor, a temperature sensor, adissolved oxygen sensor, or a combination thereof. The measurement probemay be amperometric, potentiometric, optical, capacitive, conductive, orany other suitable probe type known to those skilled in the art.

In various embodiments, the condition responsive element is in the formof a temperature responsive element or a pressure responsive element. Inthe simplest embodiments, the condition responsive element may be amechanical switch or other element that undergoes a physicaltransformation in response to an environmental trigger. For example, insome embodiments, the condition responsive element may be a bimetallicstrip (also referred to as a thermostat or thermal switch) or a shapememory alloy, such as, for example, nickel-titanium (Nitinol), whichundergoes a physical change in shape when the temperature rises above acertain threshold. In some embodiments, the materials are selected andconfigured such that the physical change occurs within a temperaturerange of 50 to 120 degrees Celsius, and more preferably, within a rangeof 100 to 115 degrees Celsius or an additional range of 60 to 110degrees Celsius and any sub-range or value therebetween. For example,the physical transformation may occur at 50° C., 55° C., 60° C., 65° C.,70° C., 75° C., 80° C., 85° C., 90° C., 91° C., 92° C., 93° C., 94° C.,95° C., 96° C., 97° C., 98° C., 99° C., 100° C., 101° C., 102° C., 103°C., 104° C., 105° C., 106° C., 107° C., 108° C., 109° C., 110° C., 111°C., 112° C., 113° C., 114° C., 115° C., 116° C., 117° C., 118° C., 119°C., or 120° C., or a range defined by any two of these values.

In other embodiments, the condition responsive element is an integratedthermal switch or pressure switch, which opens or closes an electricalcontact when a threshold temperature or pressure, respectively, has beenreached. The threshold temperature may be within the range disclosedabove. The threshold pressure may be within a range of 10 to 60 psi, andpreferably, within a range of 15 to 45 psi. The threshold pressure mayinclude any sub-range or value therebetween, including, for example, 15psi, 16 psi, 17 psi, 18 psi, 19 psi, 20 psi, 21 psi, 22 psi, 23 psi, 24psi, 25 psi, 26 psi, 27 psi, 28 psi, 29 psi, 30 psi, 31 psi, 32 psi, 33psi, 34 psi, 35 psi, 36 psi, 37 psi, 38 psi, 39 psi, 40 psi, 41 psi, 42psi, 43 psi, 44 psi, or 45 psi, or a range defined by any two of thesevalues.

In still other embodiments, the condition responsive element is anelectrical element, such as a resistive element, which produces a changein the electrical signal at least when a threshold value is reached. Insome such embodiments, the threshold value may be any of the thresholdtemperatures and pressures disclosed above. In some embodiments, thecondition responsive element may be a pressure switch or sensor or atemperature switch or sensor. The condition responsive element of someembodiments is, for example, a positive temperature coefficientthermistor, switching PCT thermistor, or other thermistor, a resistancetemperature detector (RTD), a reed switch, a piezoelectric pressuresensor, an electromagnetic pressure sensor, a capacitive pressuresensor, a piezoresistive strain gauge, or any other suitable electricalcomponent known to those skilled in the art.

The heat cycle detection unit preferably includes at least a detectionmodule, a data memory, and a data interface. The detection module anddata memory may be printed on stacked circuit cards. The detectionmodule of some embodiments is a general purpose processor. In otherembodiments, it is a Digital Signal Processor (DSP), an ApplicationSpecific Integrated Circuit (ASIC), a Field Programmable Gate Array(FPGA) or other programmable logic device, discrete gate or transistorlogic, discrete hardware components, MEMS piezoelectric pressuresensors, a micro-pressure switches, diaphragm pressure switches, or anycombination thereof designed to perform the functions described herein.A general purpose processor may be a microprocessor, but in thealternative, the processor may be any processor, controller,microcontroller, or state machine. A detection module may also beimplemented as a combination of computing devices. In some embodiments,the detection module, data memory, data interface, and any otherassociated processors and processing circuitry associated with the heatcycle detection unit may be shared between the heat cycle detection unitand the measurement device. For example, the heat cycle detectioncircuitry may be used by the measurement device or measurement probe toperform any calculations or conversions (for example, converting asignal from analog to digital, or vice versa). Thus, in addition to theheat cycle counting functionality, the processing chips or circuitry maybe integrated with any other processing or computing functionality ofthe measurement device or probe, reducing the need for duplicatecomponents. Similarly, the memory of the heat cycle detection unit maybe shared with various other components or computing or processingsystems integrated into the measurement probe or device.

The data memory may include Random Access Memory (RAM), flash memory,Read Only Memory (ROM), Electrically Programmable ROM (EPROM),Electrically Erasable Programmable ROM (EEPROM), registers, hard disk, amicro-secure digital (SD) card or other removable disk, or any othersuitable form of storage medium known in the art. The data memory iscoupled to the detection module such that the module can readinformation from, and write information to, the data memory. In some butnot all embodiments, the data memory is integral to the detectionmodule. The detection module and the data memory of some embodimentsreside in an ASIC. In alternative embodiments, the detection module andthe data memory reside as individual discrete components. As describedabove, in some embodiments, the data memory may be used to storemeasurement data (for example, information that the measurement devicemeasures when in operation, such as pH measurements from a pHmeasurement device) and non-measurement data (for example, informationnot measured by the measurement device, such as calibration information,model number, etc.).

The data interface may allow for the communication of signals andinformation from the detection module to a data output. In someembodiments, the detection module conditions and/or transformselectrical signals before they reach the data interface. Consequently,the data interface of various embodiments transmits analog and/ordigital signals. The data interface of some embodiments includes one ormore radio frequency transmitters, other wireless transmitters,couplers, universal serial buses (USB) and/or other data buses. The datainterface may comprise an eight-pin connector configured to physicallyand electrically couple to an external transmitter and power supply (notshown). Accordingly, the data interface may be configured to transferpower to/from the measurement device as well as communicate data. Insome embodiments, the data interface may be configured to provide forpower transfer and data communication concurrently or non-concurrently.In some embodiments, the measurement device includes an outputcomponent, such as, for example, a display screen or signal lights, todisplay processed data to a user. In other embodiments, the measurementdevice transmits the data to an external display screen or other outputdevice via near-field communications, radio frequency signals, Bluetoothsignals, or other wireless signals, or through a physical electricalconnection (e.g., electrical wires, cables, or connector pins) or acontactless inductive coupling interface (see e.g. DE 19540854A1, DE4344071A1, and U.S. Pat. Nos. 8,639,467, 7,785,151, 6,705,898,6,476,520, 5,325,046, and 5,293,400; each of which is incorporatedherein by reference in its entirety and for disclosure thereof). Thedata output of various embodiments includes, preferably, a count ofautoclave cycles and/or total sterilization or cleaning cyclesexperienced by the device as well as probe serial ID number,manufactured date, and other meta data useful to the operator.

In some embodiments, the data interface and/or the data output may allowfor bi-directional communication of signals and data via at least one ofa physical connection, a wireless connection, an optical connection, oran inductive connection between the data interface and/or data outputand an external device (or transmitter or base unit). In anotherembodiment, a secondary (e.g., relay) device may be configured tophysically couple with the measurement device and allow bi-directionalcommunication of signals and data to an external device (e.g., powersupply, transmitter, or base unit) via a wireless, optical, inductive,or physical connection between the secondary device and the externaldevice. In an alternate embodiment, the secondary device may beconfigured to wirelessly couple with the measurement device and providefor bi-directional communication and/or power transmission between themeasurement device and an external power supply or transmitter. In someembodiments, the relay device may include a circuit having at least onecontroller and at least one memory region. The relay device may beconfigured to receive data and/or power from the external power supplyor transmitter and forward the data and/or the power to the measurementdevice. Alternatively, the relay device may be configured to receivedata and/or power from the measurement device and transmit the data tothe external transmitter.

In some embodiments, the detection unit may be connected fixedly with afirst element of a pluggable connector coupling, to which themeasurement device housing is accommodated. A connection element (e.g.,relay unit, a transmitter, other element or circuitry capable ofprocessing a measurement signal, or a cable, etc.) may comprise a secondelement of the pluggable connector coupling, in which the circuitry ofthe connection element is accommodated, wherein, between the circuit ofthe measurement device and the circuitry of the connection element, dataand/or energy are exchangeable via the pluggable connector coupling,when the first and second elements of the pluggable coupling areconnected with one another. The pluggable connector coupling can beimplemented by usual connectors with plug and socket, via which agalvanic connection is produced. Alternatively the pluggable connectorcoupling can provide galvanic isolation between the measurement deviceand the connection element by transmitting data and/or energy via aninductive, wireless, or optical coupling between the circuit of themeasurement device and the circuitry of the connection element.Accordingly, the detection unit may be connected fixedly with a firstelement of the pluggable connector coupling and said circuit of themeasurement device may be also accommodated in this first element. Theconnection element may be included in a second element of the pluggableconnector coupling, and the circuit of the connection element may beaccommodated in the second element. Between the circuit of measurementdevice and the circuit of the connection element, data and/or energy maybe exchangeable via a pluggable connector coupling, when the first andsecond elements of the pluggable connector coupling are connected withone another. The pluggable connector coupling may provide galvanicisolation between the measurement device and the connection element bytransmitting data and/or energy via a wireless, an inductive or opticalcoupling between the circuit of the sensor unit and the circuit of theconnection element.

In some embodiments, the heat cycle detection unit additionally includesa protective housing or other casing that wholly or partially surroundsat least some of the electronic components of the measurement device.The housing may be configured to withstand high temperatures, such as,for example, at least temperatures up to 140 degrees Celsius, and/orfrom pressurized steam and moisture. The housing may be furtherconfigured to protect the electronic components disposed within thehousing from such temperatures and/or moisture. The housing may encasestacked circuit cards on which the detection module and the data memoryare printed. Additionally, the housing may include a plurality of glassor plastic-covered windows. The windows may be designed to permit theentrance of light into the interior of the housing. In such embodiments,one or more photodiodes or photovoltaic cells are included in the heatcycle detection unit to convert light energy into current or voltage. Asdescribed in more detail below, the photodiodes and photovoltaic cellsare coupled to batteries and/or capacitors within the system to helpreplace leaking current or charge. In some embodiments, the windows arecovered by a clear plastic or other suitable transparent material. Otherembodiments include no windows or only one transparent window.

In some embodiments, the measurement probe and the heat cycle detectionunit may be fixedly connected. In other embodiments, the measurementprobe and the heat cycle detection unit may be separably coupled. Insome such embodiments, the heat cycle detection unit forms, or ispositioned within, a removable cap. In other embodiments, the heat cycledetection unit is positioned within a separate transmitter or dongle.

The measurement device may further includes a vessel-coupling element.The vessel-coupling element may be configured to interact with, andsecurely connect to, a receiving port in a processing vessel. Suchreceiving ports may be positioned on the side or in the lid of aprocessing vessel or in a pipe or channel that is fluidly connected tothe processing vessel. The measurement device may couple to processingvessels via complementary threading. In other embodiments, a tri-clampor other suitable connection means is used. Once connected, a distalportion of the measurement device, comprising at least the sensor, ispositioned within an interior of the processing vessel. A proximalportion of the measurement device, comprising at least the datainterface, is positioned outside the processing vessel.

Many of the steps of a method or algorithm and functions described inconnection with the embodiments disclosed herein may be embodieddirectly in hardware, in a software module executed by a processor, orin a combination of the two. All such embodiments are contemplated andincorporated into use of the term: detection module. If implemented insoftware, the functions may be stored on, or transmitted over as, one ormore instructions or code on a tangible, non-transitorycomputer-readable medium.

The steps the detection module is configured and/or programmed toperform include: detecting a sterilization or cleaning event using thecondition responsive element, recording detection of the sterilizationor cleaning event in the data memory, and automatically powering off theheat cycle detection unit and resetting the detection module to respondagain to the next heat cycle event. The logic and processes needed toperform these functions are described in more detail below.

FIG. 1 depicts a perspective view of an exemplary embodiment of ameasurement device. FIG. 1 is a generic structure in which thepreviously described elements are located in an exemplary fashion. Themeasurement device depicted may be representative of any of theembodiments discussed herein. The location and connections of therespective elements are intended to be exemplary and not limiting.Additional embodiments may not include all of the elements depicted anddiscussed in relation to FIG. 1. Those of skill in the art willunderstand that any combination of any number of elements depicted anddescribed in relation to FIG. 1 may be combined in an embodiment of ameasurement device.

FIG. 1 shows the measurement device 100 that may include at least ameasurement probe 102, a condition responsive element 106, and a heatcycle detection unit 108. The measurement probe 102 may include a sensor104. In some embodiments, the sensor 104 is a pH sensor, a temperaturesensor, a dissolved oxygen sensor, or a combination thereof, while themeasurement probe 102 can be amperometric, potentiometric, optical,capacitive, conductive, or any other suitable probe type known to thoseskilled in the art. In various embodiment, the condition responsiveelement 106 may be a temperature responsive element or a pressureresponsive element.

The heat cycle detection unit 108 preferably includes at least adetection module, a data memory, and a data interface 112. In FIG. 1,the detection module and the data memory are not individually visible;however, they may be printed on stacked circuit cards 110.

Continuing with FIG. 1, the data interface 112 may comprise an eight-pinconnector configured to physically and electrically couple to anexternal transmitter and power supply (not shown). In some embodiments,the heat cycle detection unit 108 additionally includes a protectivehousing 114 or other casing that wholly or partially surrounds at leastsome of the electronic components of the measurement device 100.Additionally, the housing 114 in FIG. 1 may include a glass orplastic-covered window 116. FIG. 1 depicts an embodiment wheremeasurement probe 102 and heat cycle detection unit 108 are fixedlyconnected. FIG. 1 further includes a vessel-coupling element 118, which,when used to couple the measurement device 100 to a vessel, results in aproximal portion 122 of the measurement device 100 positioned outsidethe processing vessel, and a distal portion 120 position within aninterior of the processing vessel.

In a basic embodiment, such as the embodiment depicted schematically inFIG. 2, the measurement device 200 includes a sensor 204 and a conditionresponsive element 206 positioned within, or coupled to, a measurementprobe 202. The device also includes a heat cycle detection unit 208,which is preferably positioned within a transmitter, dongle, orremovable cap. In some embodiments, the condition responsive element 206is located in the heat cycle detection unit 208, rather than themeasurement probe 202. In some embodiments, the heat cycle detectionunit 208 is physically separable from the measurement probe 202. Theheat cycle detection unit 208 includes a detection module 209, a datamemory 211, and an interface 212. In one method of using the measurementdevice 200 of FIG. 2, the measurement probe 202 is disconnected from theheat cycle detection unit 208 and from any power source prior to beingplaced within an autoclave. Autoclaving is then initiated. The conditionresponsive element 206 deforms or otherwise changes shape in response tothe temperature or pressure in the autoclave increasing to near or abovea certain threshold. The set threshold for a given condition responsiveelement 206 is determined by the materials and configuration of thecondition responsive element 206. The condition responsive element 206may have a range of a few degrees within which it undergoes deformation.In some such embodiments, the condition responsive element 206 is abimetallic strip or a shape memory alloy that deforms in response to anincrease in temperature. In some embodiments, when the conditionresponsive element 206 deforms, it or another movable member in contactwith the condition responsive element 206 mechanically locks into asecond position, remaining in the second position even as thetemperature drops. In one embodiment of the method, after theautoclaving is complete, the measurement probe 202 is removed from theautoclave and connected to the heat cycle detection unit 208. During orupon connection to the measurement probe 202, the heat cycle detectionunit 208 detects the presence of an element locked in a second position.The heat cycle detection unit 208 resets the element, causing theelement to move back to a first position, and the detection module 209stores a sterilization or cleaning cycle (e.g. autoclave cycle) count inthe data memory 211. Although in some embodiments the heat cycledetection unit comprises a pressure responsive element, and thus theheat cycle detection unit is responding to a pressure change or apressure event rather than temperature events, those of skill in the artwill understand that the change in pressure within the probe oratmospheric pressure outside the probe may be associated with anautoclave cycle and also signals that a heat cycle has occurred. Asdiscussed above, the pressure event experienced and counted by thedetection module 209 may depend upon the type of pressure eventexperienced. An atmospheric pressure event may indicate a pressurechange in the atmospheric pressure (pressure outside the measurementdevice 200), which may result from an autoclave cycle. However, aninternal pressure event may result from heating of the probe duringeither a sterilization or an autoclave cycle. Thus, an internal pressureevent alone may be insufficient to distinguish a count by the detectionmodule 209 between a clean-in-place/steam-in-place and an autoclavecycle, absent additional elements in the probe as described in otherembodiments herein.

FIG. 3A provides a schematic of another measurement device embodiment.In FIG. 3A, the measurement device 300 includes a measurement probe 302having a sensor 304 electrically coupled to a measurement interface 305and a condition responsive element 306 electrically coupled to a heatcycle detection unit 308. In some embodiments, the condition responsiveelement 306 is located in the heat cycle detection unit 308, rather thanthe measurement probe 302. The sensor 304 is electrically coupled to ameasurement interface 305 configured to provide probe operators withinformation about the environmental condition being sensed by themeasurement probe 302. The condition responsive element 306 iselectrically connected to a heat cycle detection unit 308, whichincludes a detection module 309, a data memory 311, a capacitor 313, andan interface 312. In some embodiments, the interface 312 and interface305 are the same interface.

A method of operations for the measurement device embodiment of FIG. 3A,is shown in the flowchart of FIG. 3B. When describing the functions ofspecific components, reference numbers from FIG. 3A will be used. Atblock 331, the measurement device 300 is disconnected from an externalpower supply, causing the detection module 309 to power down. Themeasurement device 300 can then be placed in an autoclave chamber andsubjected to the high temperatures and pressures of an autoclave cycle.At block 332, the condition responsive element 306, which is in the formof a mechanical thermal switch or pressure switch, moves or deforms at aset threshold temperature or pressure value, respectively, with the setthreshold value determined by the physical and chemical properties ofthe switch 306. The deformation/movement of the switch 306 closes anelectrical contact within a circuit. As shown at block 333, the closingof the electrical contact within the circuit causes a capacitor orsimilar charge storage unit 313 to drain. In some embodiments, theswitch 306 returns to a first, non-deformed position when thetemperature or pressure falls below the threshold value, which returnsthe circuit to its first state. The capacitor remains drained until themeasurement device 300 is reconnected to a power supply and additionalcurrent flows to the capacitor 313. As shown in block 334, after themeasurement device 300 is reconnected to a power supply, the detectionmodule 309 powers back on and detects the discharged capacitor 313. Inresponse, as shown in block 335, the detection module 309 updates acount of heat cycle events and saves the updated count to the datamemory 311.

An additional embodiment of a measurement device is depictedschematically in FIG. 4A. As in the previous embodiment, the measurementdevice 400 includes a measurement probe 402 having a sensor 404electrically coupled to a measurement interface 405 and a conditionresponsive element 406 electrically coupled to a heat cycle detectionunit 408. In some embodiments, the condition responsive element 406 islocated in the heat cycle detection unit 408, rather than themeasurement probe 402. The heat cycle detection unit 408 includes adetection module 409, a data memory 411, and an interface 412. In thepresent embodiment, the detection module 409 is preferably amicroprocessor programmed to control the heat cycle detection unit 408and programmed to transform analog signals received from the conditionresponsive element 406 to digital signals. The interface 412 ispreferably a wireless transmitter configured to output wireless signals,such as, for example, near-field communication, Bluetooth, Wi-Fi, orradiofrequency signals. The interface 412 of some embodiments includesmultiple wireless transmitters capable of outputting multiple forms ofwireless signals. In some embodiments, the wireless signals are receivedby, and displayed on, a handheld device having a display screen, asshown in FIG. 13 and described in more detail below. Additionally oralternatively, the interface 412 of some embodiments includes a data busfor wired digital outputs. In some embodiments, the interface 412 andinterface 405 are the same interface.

In FIG. 4A, the capacitor 313 of FIG. 3A has been replaced with abattery 413. In other embodiments, the measurement device includes botha battery and a capacitor. In the depicted embodiment, the battery 413is part of the heat cycle detection unit 408, disposed within a housingunit 414. In other embodiments, the battery 413 is electrically coupledto the detection module 409 but physically separable from the heat cycledetection unit 408. In some embodiments, the battery 413 is readilyaccessible to facilitate battery replacement. In some embodiments, thebattery in FIG. 4A is a rechargeable battery. In other embodiments, adisposable battery is used. The battery 413 functions as a portablepower source, thereby allowing at least some of the electronics withinthe measurement device 400 to remain powered when the device 400 isdisconnected from an external power source. Consequently, the heat cycledetection unit 408 is configured to continue functioning when themeasurement device 400 is placed within an autoclave chamber, orotherwise disconnected from an external power source, e.g. during asteam-in-place cycle. The embodiment of FIG. 4A additionally includes apower-gathering system 415. The power-gathering system 415 can includeany portable element capable of converting energy from light intovoltage or current, such as, for example, a photodiode or a photovoltaiccell. In the embodiment of FIG. 4A, a photodiode 415 is included totrickle charge the battery 413 to help maintain charge in the system.

FIG. 4B provides a flowchart depicting a method of counting exposures tosterilization or cleaning cycles performed by the detection module 409of FIG. 4A. At block 440 the probe is disconnected from the externalpower supply and the internal battery continues to power the device. Atblock 441, the detection module 409, which is electrically coupled tothe condition responsive element 406, receives a modified signal fromthe condition responsive element 406. In the embodiments of FIGS. 4A-4B,the condition responsive element 406 is an electrical resistive element,for example, a thermistor or RTD, which experiences significant changesin resistance with changing temperature. In other embodiments, thecondition responsive element 406 is a pressure sensor, which generates achanged signal, for example, due to a change in resistance orinductance, as the internal probe pressure or surrounding pressurechanges. The detection module 409 of various embodiments is configuredto detect changes in the received signal. The detection module 409 isalso programmed to determine, using known equations, when the changedsignal indicates that a select threshold temperature or pressure hasbeen reached.

In other embodiments (not shown), the condition responsive element is acondition responsive circuit that includes a thermal or pressure switch.In some such embodiments, when the temperature or pressure rises near orabove a threshold level, the thermal switch or pressure switch changesstate, causing the condition responsive circuit to open. The detectionmodule (which receives power from a battery to which it is connected viaan alternate circuit), detects the cessation of current in the conditionresponsive circuit. In other such embodiments, when the temperature orpressure rises near or above a threshold level, a thermal switch orpressure switch changes state, causing a condition responsive circuit toclose. The detection module (which receives power from a battery towhich it is connected via an alternate circuit), detects the flow ofcurrent in the condition responsive circuit. Through such mechanisms,the detection module, in effect, detects that the threshold temperatureor pressure value has been reached.

As shown at block 442 and 443, when the detection module 409 detectsthat the threshold temperature or pressure has been reached, the countof heat cycle events is updated and saved in the data memory 411. Insome embodiments, the detection module 409 increments a counter andstores the new count within the data memory 411. In other embodiments,the detection module 409 stores the date and, optionally, the time ofheat cycle (e.g. autoclave) detection in the data memory 411.

To protect the circuitry from malfunctioning due to extreme temperaturesand/or pressures, the detection module 409 then optionally powers down,as shown at block 444 (if the circuitry of the device can operatereliably and predictably under high temperature/pressure, the deviceneed not power down). To better protect the circuitry, in someembodiments, a threshold temperature or pressure is selected that islower than the ranges described above. For example, in biotechnology,measurement probes are often used to monitor processes occurring at atemperature range around 37 degrees Celsius, such as, for example, 35-40degrees Celsius. In such industries, measurement devices may be selectedhaving a threshold temperature of 60-70 degrees Celsius, for example. Itwill be appreciated by those having ordinary skill in the art that anythreshold temperature or pressure may be selected for countingsterilization or cleaning cycles that is above the maximum temperatureor pressure experienced by the measurement device during normal(non-sterilization or cleaning) operations.

An additional embodiment of a measurement device is depictedschematically in FIG. 5A. As in the previous embodiment 4A, themeasurement device 500 includes a measurement probe 502 having a sensor504 electrically coupled to a measurement interface 505 and a conditionresponsive element 506 electrically coupled to a heat cycle detectionunit 508. In some embodiments, the condition responsive element 506 islocated in the heat cycle detection unit 508, rather than themeasurement probe 502. The heat cycle detection unit 508 includes adetection module 509, a data memory 511, and an interface 512. In thepresent embodiment, the detection module 509 is preferably amicroprocessor programmed to control the heat cycle detection unit 508.The interface 512 is preferably a wireless transmitter configured tooutput wireless signals, such as, for example, near-field communication,Bluetooth, Wi-Fi, or radiofrequency signals. The interface 512 of someembodiments includes multiple wireless transmitters capable ofoutputting multiple forms of wireless signals. In some embodiments, thewireless signals are received by, and displayed on, a handheld devicehaving a display screen (not shown in this figure, but shown in FIG. 13and described in more detail below). Additionally or alternatively, theinterface 512 of some embodiments includes a data bus for wired digitaloutputs. In some embodiments, the interface 512 and interface 505 arethe same interface.

In FIG. 5A, the capacitor 313 of FIG. 3A may be replaced with a battery513 and a signal filter element 514, such as a capacitor or similarcharge storage element or a timer element. In the depicted embodiment,the battery 513 is part of the heat cycle detection unit 508, disposedwithin a housing unit 515. In other embodiments, the battery 513 iselectrically coupled to the detection module 509 but physicallyseparable from the heat cycle detection unit 508. In some embodiments,the battery in 513 is readily accessible to facilitate batteryreplacement. In some embodiments the battery in FIG. 5A is arechargeable battery. In other embodiments, a disposable battery isused. The battery 513 functions as a portable power source, therebyallowing at least some of the electronics within the measurement device500 to power up on its own when the device 500 is disconnected from anexternal power source. Consequently, the heat cycle detection unit 508is configured to power on when the measurement device 500 is placedwithin an autoclave chamber (or otherwise disconnected from and externalpower source) and the condition responsive element 506 changes statewhen it exceeds its threshold limit.

FIG. 5B provides a flowchart depicting a method of counting exposures tosterilization or cleaning cycles performed by the detection module 509of FIG. 5A. At block 550 the device has been disconnected from anexternal power source whereupon the device automatically powers down. Atblock 551, the condition responsive element 506, in this embodiment athermal switch, changes state in response to the temperature risingabove the threshold value. Another embodiment may replace the thermalswitch with a pressure switch. This change in state closes (oralternatively opens, depending on the circuit architecture) the thermalswitch which in turn supplies internal battery power 513 to thedetection module 509 and the memory 511 and activates a signal filter,such as a timer 514, or charges a capacitor. Thus, the heat cycledetection module 508 may automatically power on. At block 552 thedetection module 509 increments the heat cycle counter, and saves thenew number in memory 511. In block 553, the timer expires or reaches athreshold time, or alternatively the capacitor completely charges, andthis may cause power to be automatically shut off to the detectionmodule and memory which in turn saves battery power and protects themicroprocessor in 509 and other components of the detection unit 508from operating in the excessive heat of an autoclave cycle. In block554, the heat cycle event ends, the probe's temperature sinks back downpast the threshold value of the thermal switch (or pressure switch) 506,the switch changes back to its original open state (or alternativelyclosed state, depending on the circuit architecture), the battery isdisconnected from the circuit, and the timer resets, or the capacitordischarges. As a result of the automatic actions in block 554 the deviceis now in a state represented by block 555 where the device is now off,conserving the battery 513, and ready to automatically and autonomouslypower on again when the next heat cycle begins.

The signal filter 514 (e.g., a timer or capacitor element) serves thepurpose of filtering signals from the condition responsive element 506,such that multiple changes in state of the condition responsive elementduring the period where the timer or capacitor element is activated, buttime has not yet expired (or capacitor discharged) will not be countedas multiple heat cycles. For example, if the temperature or pressurefluctuates near the threshold of the condition responsive element, a thecondition responsive element may change between states several timesuntil the heat cycle event progresses past the threshold temperature orpressure sufficiently for the condition responsive element to remain ina changed state. By utilizing a timer or capacitor element, the devicebe ready to record a new heat cycle event only after the timer expiresor reaches a threshold time (or the capacitor is discharged). Thus, theamount of time required to filter out these fluctuations will depend onthe type of heat cycle and sensitivity of the condition responsiveelements. One of skill in the art will be able to determine the requiredamount of time. It is contemplated that the amount of time will be fromabout 5 seconds to as much as 5 minutes, or 5 seconds to 2 minutes, or30 seconds to 5 minutes. In some embodiments, the amount of time will be0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15 minutes, or a range definedby any two of the preceding values. Filters other than the timer orcapacitor element to filter the signal from the condition responsiveelement to avoid false heat cycle counts will be apparent to those ofskill in the art.

FIG. 6A provides a schematic of another embodiment of a measurementdevice 600 having a battery 613 and a heat cycle detection unit 608. Theheat cycle detection unit 608 includes a detection module 609, a datamemory 611, and an interface 612. As in previous embodiments, themeasurement device 600 also includes a measurement probe 602 with asensor 604 electrically coupled to a measurement interface 605. In otherembodiments, the sensor 604 is electrically coupled to the detectionmodule 609. In such embodiments, the detection module 609 is configuredto amplify the signal received from the sensor 604 and convert it to adigital output. The digital output can then be provided to an outputdevice via the interface 612 in a similar manner as the sterilization orcleaning count data that is transmitted to an output device via theinterface 612. In addition, in some embodiments a signal filter (e.g.capacitor or other charge storage unit, or timer) (not shown) isincluded and functions as described in FIG. 5.

The measurement device 600 of FIG. 6A also has a vessel coupling device618, which is configured to secure the measurement device 600 to aperimeter wall or lid (i.e., the body) of a processing vessel. Invarious embodiments, the measurement device 600 is secured to the bodyof a processing vessel such that a distal portion 620 of the measurementdevice 600 is disposed within an interior cavity of the vessel and aproximal portion 622 of the measurement device 600 is positioned outsidethe vessel.

In some embodiments, the measurement device includes only one conditionresponsive element. In such embodiments, if the condition responsiveelement is a proximal condition responsive element, which is typicallybut not necessarily positioned on or within a proximal portion of themeasurement device, it will not respond to temperature or pressurechanges that occur within the processing vessel, if the proximal portionof the measuring device is sufficiently insulated from temperatureand/or pressure of the distal portion of the measuring device.Consequently, if a steam-in-place cycle or clean-in-place cycle is runwithin the processing vessel, the proximal condition responsive elementwill not respond, and the sterilization or cleaning cycle will not becounted. In contrast, autoclaving requires placement of the entiremeasurement probe within an autoclave chamber. Consequently, a proximalcondition responsive element will experience the elevated temperaturesand pressures of an autoclave cycle. Thus, when only a proximalcondition responsive element is used, the measurement device is tailoredto count, specifically, autoclave cycles.

Conversely, if only one condition responsive element is present and itis a distal condition responsive element, typically but not necessarilylocated in the distal portion of the measurement device, the distalcondition responsive device will be subjected to any elevatedtemperatures and pressures that occur within the processing vessel aswell as elevated temperatures and pressures that occur while themeasurement device is disposed within an autoclave chamber. In suchembodiments, the measurement device is configured to detect and countmultiple forms of sterilization or cleaning cycles, although it may notdistinguish between the types of cycles detected. Each detected cycle iscounted and stored in memory as a generic sterilization or cleaningcycle.

In some measurement device embodiments, such as the embodiment of FIG.6A, the measurement device 600 includes both a distal conditionresponsive element 606, typically but not necessarily positioned on orwithin the distal portion 620 and a proximal condition responsiveelement 607, typically but not necessarily positioned on or within theproximal portion 622. Such embodiments may be configured to detect andcount multiple forms of heat cycles and distinguish between the variousforms. The detection of a response by the proximal condition responsiveelement 607 with or without a response by the distal conditionresponsive element 606 may indicate that an autoclave sterilizationprocess is detected, and that detected cycle may be counted and storedin memory as an autoclave cycle. However, if the distal conditionresponsive element 606 responds but the proximal condition responsiveelement 607 does not respond, then the detected cycle is either aclean-in-place or a steam-in-place.

A method of detecting, distinguishing, and counting various forms ofsterilization or cleaning is provided in the flowchart of FIG. 6B. Asshown in block 660, the detection module 609 receives a modified signalfrom a condition responsive element 606 and/or 607 as the temperature orpressure rises. From the modifications in the signal, the detectionmodule 609 determines when a threshold temperature or pressure has beenreached, as shown in block 661. In block 662, the detection module 609determines whether the modified signal is being received from theproximal condition responsive element 607. If it is, then the entiremeasurement device 600 is being subjected to an elevated temperatureand/or pressure, and one can conclude that the measurement device 600 isin an autoclave chamber undergoing an autoclave cycle. In such cases,the detection module 609 is programmed to update a count of autoclavecycles (and/or a count of generic sterilization or cleaning cycles) asindicated in block 666, save the updated count in the data memory 611 asindicated in block 667, and optionally power down the detection module609 to protect the electronics in the heat cycle detection unit 608 orsave power, as indicated in block 668.

If the detection module 609 determines that the modified signal is notbeing received from the proximal condition responsive element 607, (andthus, is instead coming from only the distal condition responsiveelement 606), the detection module 609 is programmed to update a countof steam-in-place cycles (and/or a count of generic sterilization orcleaning cycles) as indicated in block 663, and save the updated countin the data memory 611 as indicated in block 664. The detection module609 may optionally be programmed to power down in response to detectingthe heat cycle, although such programming is not as important forsteam-in-place cycles when the heat cycle detection unit electronics arelocated outside the processing vessel, although it may be desirable topower down to save battery power during the heat cycle process if thedevice is battery powered.

FIG. 7A schematically depicts an embodiment of a measurement device 700configured to detect clean-in-place cycles, along with, preferably,autoclave cycles. The provided measurement device 700 includes a heatcycle detection unit 708 having an interface 712, a data memory 711, adetection module 709, and a battery 713. The measurement device 700 alsoincludes a measurement probe 702 having a pH sensor 704 disposed on orwithin the probe 702. The pH sensor 704 of the current embodiment iselectrically coupled to the heat cycle detection unit 708. In someembodiments, the pH sensor 704 is provided to help detect clean-in-placecycles, and the measurement probe 702 includes one or more other sensorsconfigured to sense a condition of the processing medium. In otherembodiments, the pH sensor 704 serves as both the primary sensor of themeasurement probe 702 and the sensor used during detection ofclean-in-place cycles, and thus may be coupled to an interface (notshown) which is used during normal operation for monitoring pH levels.

In FIG. 7A, a vessel coupling device 718 is permanently or separablyaffixed to an outer portion of the measurement probe 702. A first distaltemperature responsive element 706, is typically but not necessarilypositioned on or within a distal portion 720 of the measurement device700, and a proximal condition responsive element 707, is typically butnot necessarily positioned on or within a proximal portion 722 of themeasurement device 700.

FIG. 7B depicts one embodiment of a method performed by the measurementdevice of FIG. 7A when counting clean-in-place and other heat cycleevents. The detection module 709 receives signals from one or more ofthe condition responsive elements 706 and 707, and the signals change asthe temperature or pressure increases and/or crosses a threshold. Asshown in blocks 770 and 771, detection module 709 receives a modifiedsignal from at least one condition responsive unit, and from the signal,determines when a threshold value has been reached. The detection module709 also performs the operation in block 772 to determine if themodified signal was received from the proximal condition responsiveelement 707. If it was, then the detection module 709 follows theautoclave detection protocol described previously. As shown in blocks773-775, the detection module 709 updates a count of autoclave cycles,saves the updated count to the data memory 711, and optionally powersdown (if the circuitry of the device can operate under hightemperature/pressure, or conserving battery power is not desired/needed,the device need not power down). If the modified signal was not receivedfrom the proximal condition responsive element 707, (and thus, isinstead coming from only the distal condition responsive element 706),the detection module 709 processes signal inputs from the pH sensor 704.In block 776, the device determines if any measurement reading from thepH sensor 704 exceeds a clean-in-place pH threshold within a definedtime period, and if so, a clean-in-place detection protocol is performed(blocks 777-778). If no pH reading exceeds the clean-in-place thresholdduring the defined time period, the steam-in-place detection protocol isperformed (block 779-780). The clean-in-place protocol, shown in blocks777 and 778, involves updating a count of clean-in-place cycles andsaving the updated count to the data memory 711. Similarly, thesteam-in-place protocol, shown in blocks 779 and 780, includes updatinga count of steam-in-place cycles and saving the updated count to thedata memory 711. The detection module 709 can further be optionallyprogrammed to shut down in response to detection of a steam-in-placecycle and/or a clean-in-place cycle, for example, to save battery power.

In some embodiments, the clean-in-place threshold is at least 60 degreesCelsius and less than 100 degrees Celsius. Typically, the clean-in-placethreshold is between 65 and 90 degrees Celsius, and it can include anysub-range or individual value within that disclosed range, including 65,70, 75, 80, 85 and 90 degrees Celsius. In some embodiments, the pHthreshold is within the ranges of either 9 to 14 pH or 1 to 4 pH and maybe any sub-range or individual value therebetween. For example, theclean-in-place pH threshold of some embodiments is 9, 10, 11, 12, 13, or14. In some embodiments, the defined period of time is between about 30seconds and about 5 minutes, and includes any sub-range or individualvalue therebetween, including 0.5-4, 0.5-3, 0.5-2, 1-5, 1-4, 1-3, 1-2,2-5, 2-4, and 2-3 minutes. The defined period of time includes both theabout 30 seconds to about 5 minutes preceding thetemperature-threshold-reaching event and the about 30 seconds to about 5minutes following the temperature-threshold-reaching event.

In some embodiments of a measurement device, the measurement device maycomprise an autonomous smart monitoring system as described above. Themeasurement device may both automatically power on and automaticallypower itself off at certain points in a heat sterilization or cleaning,or autoclave cycle, without external control and power. This automaticpower on and/or off feature may advantageously provide for more accuratecounting of heat cycles as well as provide better power management ofthe battery and thus longer shelf life of the probe. For example,without an automatic power on feature in embodiments where cycle countsare only recorded after the device powers on, only one cycle will becounted if multiple successive heat cycles are performed on ameasurement device without turning it on between cycles. In someembodiments, that cycle is counted during the cycle, just prior to themeasurement device shutting down. In other embodiments, a cycle iscounted when the measurement device powers back on, for example, bydetecting a drained capacitor. By either method it is desirable to havethe probe automatically power on whenever a heat cycle begins again. Byautomatically powering back on as a cycle starts, the measurement deviceof the current embodiment is ready to detect and count each new cyclethat occurs. By use of a thermal switch as a condition responsiveelement the device can be configured to automatically power on each timethere is a new heat cycle. Furthermore, since the device canautomatically power on at the beginning of the heat cycle, there is noneed to keep it on after the counter is incremented and the device canshut itself off for the remainder of the cycle to conserve the batteryand protect the functionality of the microprocessor during excessiveheat.

Measurement device embodiments that perform the method of FIG. 8 includean integral power supply, such as a battery. In some embodiments, both abattery and a capacitor are included. In some embodiments the powersupply is augmented by a portable power supply such as an attachablebattery. In block 880 the device is in a state of complete power down.The device is disconnected from the external power supply and theinternal battery power is turned off. In block 881 the conditionresponsive element changes state at a pre-determined temperaturethreshold (or pressure threshold), and switches power on to the device.In block 882 the detection module signals that a heat cycle has begun,for example by detecting that a capacitor has been discharged or chargedin response to a change in state of the condition responsive element orby directly detecting the change of state of the condition responsiveelement itself. In block 883 the count is incremented by 1 in memory andsaved. In block 884 the device powers off the microprocessor for it tobetter endure the extreme temperatures of an autoclave cycle and toconserve the internal battery. In block 885 the probe's temperaturecools to below the temperature threshold (or pressure drops below thepressure threshold) of the condition responsive element, the element'sstate changes back to the original state. In block 886 the device isonce again completely powered down and ready to automatically count thenext heat cycle. Where a capacitor is present, it can be returned to itspre-cycle state, for example being recharged by the battery, and is thusready for the next cycle.

Another method performed by some embodiments of a measurement device isprovided in the flowchart of FIG. 9. In the depicted method, themeasurement device can both automatically shut itself off andautomatically turn itself back on at certain points in a heatsterilization or cleaning, e.g., autoclave cycle.

Measurement device embodiments that perform the method of FIG. 9 includea portable power supply, such as a battery. In some embodiments, both abattery and a capacitor are included. In block 990 at least the heatcycle detection portion of the device is powered on. As shown in blocks991-994, the detection module of such measurement devices detects that athreshold temperature or pressure has been reached, updates a count ofheat cycle event (e.g. autoclave), saves the updated count in the datamemory, and optionally powers down (if the circuitry of the device canoperate under high temperature/pressure, or battery power conservationis not desired, the device need not power down). In one embodiment, athermal or pressure switch is used. When a threshold temperature orpressure is reached, the switch physically deforms and opens a circuitconnecting the switch, capacitor, battery, and detection module. Whenthis occurs, the battery no longer provides voltage and current to thedetection module, and the capacitor or other charge storage unit beginsto drain. The detection module receives current from the drainingcapacitor long enough to detect the opened switch and record theoccurrence of a heat cycle event (sterilization or cleaning) in the datamemory. The detection module powers down as the current wanes. As shownin block 995, when the temperature or pressure falls below a secondthreshold value (also referred to as a power-on temperature orpressure), the switch returns to its first, non-deformed position, whichcompletes the circuit. Charge and voltage from the battery are againdelivered to the detection module, and the detection module turns backon. In embodiments having one universal switch that functions to bothpower off and power on the detection module, the first threshold valueand second threshold value are generally equal. Shape memory materialsand bimetallic strips are generally configured to deform and reform totheir original shapes at substantially similar or equal temperatures.

In an alternative embodiment, the detection module may perform blocks991-994 in response to receiving a changing signal from an electricalcondition responsive element. From the change in signal, the detectionmodule is configured to calculate/detect that a first threshold valuehas been reached. In such an embodiment, a second condition responsiveelement in the form of a mechanical switch is included in a secondcircuit in the measurement device. The detection module is configured toautomatically power up, as recited in block 995, when the mechanicalswitch changes state an electrical contact closed in the second circuit.This occurs when a second threshold value is reached. In suchembodiments, the first threshold value may be the same or different thanthe second threshold value. In some embodiments, the counter incrementsafter the heat cycle ends, rather than at the start of the heat cycle.

FIG. 10 depicts a circuit diagram of one embodiment of a heat cycledetection unit. This particular embodiment automatically detects andrecords heat cycles according to the embodiment described with referenceto FIG. 5B. FIG. 11 is a schematic of a circuit diagram of oneembodiment of a heat cycle detection unit.

FIG. 12A provides a schematic of another embodiment of a measurementdevice 1200 having a battery 1213 and a heat cycle detection unit 1208.The heat cycle detection unit 1208 includes a detection module 1209, adata memory 1211, and an interface 1212. As in previous embodiments, themeasurement device 1200 also includes a measurement probe 1202 with asensor 1204 electrically coupled to a measurement interface 1205. Inother embodiments, the sensor 1204 is electrically coupled to thedetection module 1209. In such embodiments, the detection module 1209 isconfigured to amplify the signal received from the sensor 1204 andconvert it to a digital output. The digital, output can then be providedto an output device via the interface 1212 in a similar manner as thesterilization or cleaning count data that is transmitted to an outputdevice via the interface 1212. In addition, in some embodiments a signalfilter such as a timer 1214 is included and functions as described inFIGS. 5A and B.

The measurement device 1200 of FIG. 12A also has a vessel couplingdevice 1218, which is configured to secure the measurement device 1200to a perimeter wall or lid (i.e., the body) of a processing vessel. Invarious embodiments, the measurement device 1200 is secured to the bodyof a processing vessel such that a distal portion 1220 of themeasurement device 1200 is disposed within an interior cavity of thevessel and a proximal portion 1222 of the measurement device 1200 ispositioned outside the vessel.

In some measurement device embodiments, such as the embodiment of FIG.12A, the measurement device 1200 includes both a distal conditionresponsive element 1206, typically but not necessarily positioned on orwithin the distal portion 1220 and a proximal condition responsiveelement 1207, typically but not necessarily positioned on or within theproximal portion 1222. Such embodiments may be configured to detect andcount multiple forms of heat cycles and distinguish between the variousforms. In an embodiment, the condition responsive element 1207 may be anRTD. The detection of a response by the proximal condition responsiveelement 1207 with or without a response by the distal conditionresponsive element 1206 may indicate that an autoclave sterilizationprocess is detected, and that detected cycle may be counted and storedin memory as an autoclave cycle. However, if the distal conditionresponsive element 1206 responds but the proximal condition responsiveelement 1207 does not respond, then the detected cycle is either aclean-in-place or a steam-in-place.

A method of detecting, distinguishing, and counting various forms ofsterilization or cleaning is provided in the flowchart of FIG. 12B. Atblock 1260 the device has been disconnected from an external powersource whereupon the device automatically powers down. At block 1261,one or more condition responsive elements 1206 and 1207, in thisembodiment thermal switches, changes state in response to thetemperature rising above the threshold value. This change in statecloses the thermal switch which in turn supplies internal battery power1213 to the detection module 1209 and the memory 1211 and activates atimer 1214. Thus, the heat cycle detection module 1208 may automaticallypower on. Another embodiment may replace the thermal switches withpressure switches.

The detection module 1209 monitors the temperature/pressure over a timeperiod or after a time period, as shown in block 1262. The detectionmodule 1209 determines whether a second threshold temperature orpressure which is higher than the first threshold has been reached byany of the condition responsive elements, as shown in block 1263. If thesecond threshold temperature or pressure has not been reached, then thedetection module 1209 increments the clean-in-place cycle counter, asindicated in block 1264, saves the updated count in the data memory 1211as indicated in block 1265, and optionally powers down the detectionmodule 1209, as indicated in block 1266.

If the second threshold temperature or pressure has been reached, thenthe detection module 1209 must determine from which condition responsiveelement 1206 or 1207 the signal of the temperature or pressure exceedingthe second threshold is being received, as indicated in block 1270. Ifthe detection module 1209 determines that the temperature or pressureabove the second threshold is being received from the proximal conditionresponsive element 1207, then the entire measurement device 1200 isbeing subjected to an elevated temperature and/or pressure, and one canconclude that the measurement device 1200 is in an autoclave chamberundergoing an autoclave cycle. In such cases, the detection module 1209is programmed to update a count of autoclave cycles (and/or a count ofgeneric sterilization or cleaning cycles) as indicated in block 1271,save the updated count in the data memory 1211 as indicated in block1272, and power down the detection module 1209, as indicated in block1273, although powering down is optionally not performed if protectionof the device and/or power conservation is not an desired. If thedetection module 1209 determines that the temperature or pressure abovethe second threshold is being received from the distal conditionresponsive element 1206 and not the proximal condition responsiveelement 1207, then only the distal portion of the measurement device1200 is being subjected to an elevated temperature and/or pressure, andthe measurement device 1200 is being subjected to a steam-in-placecycle. In such cases, the detection module 1209 is programmed to updatea count of steam-in-place cycles (and/or a count of genericsterilization or cleaning cycles) as indicated in block 1275, save theupdated count in the data memory 1211 as indicated in block 1276, andoptionally power down the detection module 1209, as indicated in block1277.

In an alternate embodiment, the condition responsive element may be usedin conjunction with a heat detection unit RTD responsive to temperaturechanges in and/or around the distal portion of the measurement device (a“distal RTD”). The distal RTD may operate, after powering up due to acondition responsive element changing state in response to thetemperature/pressure rising above a threshold value, to determine if theheat cycle event is a clean-in-place cycle or a higher temperaturecycle, such as a steam-in-place or autoclave cycle. The distal RTD usedto analyze the heat cycle event may be independent from any RTD used bythe measurement device. In an alternate embodiment, the distal RTD usedby the heat cycle detection unit is also used by the measurement device.

In another embodiment, a distal condition responsive element may beinstalled along with a heat detection unit RTD responsive to temperaturechanges in and/or around the distal portion of the measurement device (a“distal RTD”), with an additional heat detection unit RTD responsive totemperature changes in and/or around the proximal portion of themeasurement device (a “proximal RTD”). Thus, the distal RTD, preferablylocated in the distal portion of the measurement device, may function asa distal condition response element, while the proximal RTD, preferablylocated in the proximal portion of the measurement device, may functionas a proximal condition response element. In this embodiment, the twoRTDs may be evaluated together to determine the type of heat cycleevent. The two RTDs may function similarly to the discussion aboveregarding proximal and distally condition response elements anddetection of clean-in-place, steam-in-place, and autoclave cycles. Thus,when the proximal RTD temperature is above a threshold temperature andthe distal RTD is either above or below the threshold temperature, theheat cycle counter will increment the autoclave cycle count. If thedistal RTD registers above a threshold but the proximal RTD is below athreshold, then the heat cycle counter will increment either aclean-in-place or a steam-in-place, dependent upon the distal RTDtemperature reading. As discussed above, the distal RTD used to analyzethe heat cycle event may be independent from any RTD used by themeasurement device. In an alternate embodiment, the distal RTD used bythe heat cycle detection unit is also used by the measurement device.

FIG. 13 depicts a diagram of an embodiment of a handheld device that maycouple with a measurement device. In some embodiments, the handhelddevice 1300 described above may be configured to physically couple toany of the measurement devices disclosed herein, including devices 100,200, 300, 400, 500, 600, or 700, and electrically couple to therespective interfaces (for example, interface 212, 312, 412, 512, 612,or 712, respectively). For simplicity, measurement device 200 andinterface 212 will be used to describe the functionality of the handhelddevice 1300. However, any discussion related to the handheld device 1300and the measurement device 200 and interface 212 will be understood toapply to any other of the measurement devices disclosed herein, e.g.,measurement devices 100, 200, 300, 400, 500, 600, or 700 and theirrespective interfaces.

The handheld device 1300 comprises a circuit board enclosed within ahousing 1301. The housing 1301 may comprise cutouts for a connector1305, a screen 1310, and one or more buttons 1315. In some embodiments,the housing 1301 may further comprise a cutout for a connector (orcable) 1320 and/or one or more additional connectors 1305. The housing1301 may be formed of a material that isolates and insulates theenclosed circuit board from external forces and events. In embodimentshaving connectors 1305, the housing 1301 may comprise removable caps orcovers configured to provide a sealed enclosure when the caps or coversare affixed over or within the connectors 1305. The circuit boardenclosed within the housing 1301 may comprise an energy source (forexample a battery), energy source connector, or energy storage deviceconfigured to provide power to the handheld device 1300 and anyconnected measurement device 200. The circuit board may also compriseall the circuits and components necessary to perform the functions ofthe handheld device 1300 described herein. In some embodiments, thehandheld device 1300 may not comprise any connectors 1305 and mayinstead communicate with other devices (for example, the measurementdevice 200 or an external computing device via any wirelesscommunication method). In some embodiments, the handheld device 1300 maybe capable of both wireless communication and communication viaconnectors 1305. In some embodiments, the handheld device 1300 maycomprise a communication circuit. The communication circuit may compriseone or more components that enable the handheld device 1300 tocommunicate with one or more measurement devices 200 or externalcomputing devices. The communication circuit may enable the handhelddevice 1300 to communicate via any connected, wired, or wireless methods(for example via copper contacts, via a network cable, or via wirelesscommunications).

In some embodiments, the housing 1301 may be generally rectangular withcontours and beveled edges leading to the connector 1305, which may belocated at a bottom surface of the housing 1301. The screen 1310 may berectangular and situated on a front surface of the housing 1301. Thescreen 1310 may be located closer to a top surface of the housing 1301and may be framed by the housing 1301. The button 1315 may be circularand may be situated below the screen 1310 and above the bottom surface.

In some embodiments, the handheld device 1300 may comprise the connector1305 configured to create physical and electrical connections with themeasurement device 200, for example via a VarioPin connector and/orVarioPin cables. In some embodiments, the connector 1305 may beintegrated with a cable (not shown in this figure) connected to thehandheld device 1300. In other embodiments, the connector 1305 isinstead a protruding connector (not shown in this figure) that maycouple with a connector on the measurement device 200 with which thehandheld device 1300 is being coupled. Other physical connectors knownin the art may be used, e.g., as shown in FIG. 13, the connector maycomprise a receptacle configured to receive a connector from a cable ora sensor. In other embodiments, the handheld device 1300 may comprise awireless communication means (not shown in this figure, for example, asBluetooth communication device, an infrared communication device, aradio frequency communication device, or a wireless communicationdevice) configured to allow for wireless communication with theinterface 212 (or interface 412, wherein the interface 212 is configuredto participate in wireless communications. In some embodiments, thehandheld device 1300 may comprise both the connector 1305 and one ormore wireless communication means.

In some embodiments, the handheld device 1300 may further comprise thescreen 1310, wherein the screen 1310 may be configured to displayinformation received by the handheld device 1300 from the measurementdevice 200. For example, the screen 1310 may display informationregarding the number of heat cycle counts detected by the measurementdevice 200 or may display identifying information regarding theconnected measurement device 200, for example a serial number of themeasurement device 200 or a user established identifier, for example, apart number or a device name in the user's control system. In someembodiments, the handheld device 1300 may be configured to automaticallyextract or read information from the connected measurement device 200and display that information on the screen 1310. For example, when themeasurement device 200 is connected to the handheld device 1300, thescreen 1310 may automatically display the measurement device 200identifying information (for example, the serial number or user devicename, as described above) or the total sterilization cycles count (forexample, including one or more of an autoclave cycle count, asteam-in-place cycle count, a clean-in-place cycle count, etc.).

In some embodiments, while the one or more cycle counts are displayed onthe screen 1310 of the handheld device 1300, the button 1315 (or otherinput means, for example a switch, a touch sensor, a light sensor) maybe actuated to clear or reset a selected cycle count field. In someembodiments, the handheld device 1300 may be configured to display adifferent field associated with information from the measurement device200 when the button 1315 is actuated. For example, the screen 1310 maydisplay autoclave cycle counts when the measurement device 200 isinitially connected to the handheld device 1300. In some embodiments,the single button 1315 may be replaced with multi-directional singlebutton that may be configured to allow multiple actuations from a singlephysical button 1315 (for example, a single button 1315 with directionalarrows for use in navigating through menus, etc.).

Actuation of the button 1315 may cause the screen 1310 to display theidentifying information for the measurement device 200 or calibrationparameters of the measurement device 200 (for example, the slope,offset, or % efficiency). In some embodiments, the button 1315 may beactuated to display on the screen 1310 manufacturing data of theconnected measurement device 200 or the handheld device 1300 itself. Forexample, the screen 1310 may be used to display manufacturing dataincluding the serial number of the measurement device 200, amanufacturer's part number of the measurement device 200, performancedata of the measurement device 200, or date of calibration or othertests performed on the measurement device 200. Similar information maybe displayed on the screen 1310 regarding the handheld device 1300 (forexample, serial number, part number, manufacturing date, etc.). In someembodiments, the screen 1310 may be configured to display user datafields stored in either the measurement device 200 or the handhelddevice 1300. These user data fields may comprise a measurement devicename or tag, an experiment name, an operator name, a lot number, or afree form field that may be used for storage of any information desiredby the user.

In some embodiments, the handheld device 1300 may be unable to receiveand display measurement data from the measurement device 200. In suchembodiments, the handheld device 1300 may be configured to receive anddisplay only sterilization cycle counts of the measurement device 200,calibration parameters of the measurement device 200, manufacturing dataof the measurement device 200, and customer customizable data fields ofthe measurement device 200.

In some embodiments, the connector 1320 may comprise a connector thatallows the handheld device 1300 to be physically connected to a computeror some other external computing device (for example, a smartphone, alaptop computer, or a third party configuration device). For example,the connector 1320 may comprise an USB port, a Firewire port, or anyother unidirectional or bidirectional physical communication interface.In some embodiments, the wireless communication means described above asallowing wireless communications with the interface 212 (or, forexample, interface 412 and/or interface 512, described above as beingcapable of wireless communication) of the measurement device 200 mayalso be used to allow wireless communication with the external computingdevice instead of or in addition to using the connector 1320. Connectingthe handheld device 1300 to the external computing device via theconnector 1320 or wirelessly may allow the user to write data to theuser data fields of the measurement device 200 or review informationstored in the measurement device 200 or the handheld device 1300. Insome embodiments, connecting the handheld device 1300 to the externalcomputing device may allow the user to calibrate the measurement device200 using any known calibration technique (for example, two pointcalibration) via the handheld device 1300. In some embodiments, thehandheld device 1300 may be configured to allow calibration of themeasurement device 200 without being connected to the external computingdevice (for example, allow the user to calibrate the measurement device200 using only the handheld device 1300).

The handheld device 1300 may slip onto the connector of the measurementdevice 200 and may instantly read data stored in the measurement device200. In some embodiments, the handheld device 1300 may default to firstdisplaying the sterilization cycle count for the connected measurementdevice 200. In some embodiments, the handheld device 1300 may default todisplaying a menu of available options or fields for viewing related tothe measurement device 200. In some embodiments, the data read by thehandheld device 1300 (when physically connected or when wirelesslyconnected) may comprise non-measurement data from the measurement device200, for example, heat sterilization cycle counts or calibrationinformation. In some embodiments, the handheld device 1300 may befurther configured to read measurement data from the measurement device200, for example, the measured pH from a pH measurement device 200.

In some embodiments, the handheld device 1300 may be configured to allowcopying of information from a first measurement device 200 to a secondmeasurement device 200. In some embodiments, the first measurementdevice 200 and the second measurement device may both be connected tothe handheld device 1300 at the same time. In some embodiments, thefirst and second measurement devices 200 may be connected one after theother, wherein the handheld device 1300 may be configured to store datafrom the first measurement device 200 to be sent to the secondmeasurement device 200 at a later time. Such capabilities of thehandheld device 1300 may allow the user to replace the first measurementdevice 200 with the second measurement device 200 and copy allparameters from the first measurement device 200 to the secondmeasurement device 200 to simplify the replacement process. For example,the customer data fields or any parameter fields may all be copied. Insome embodiments, the calibration parameters may be copied via theprocess described above. In some embodiments, the current number ofcycle counts may be copied via the process described above.

In some embodiments, one or both of the handheld device 1300 and/or themeasurement device 200 may be configured to power on automatically whenthe handheld device 1300 is connected to the measurement device 200.When the handheld device 1300 is powered on when either connected to themeasurement device 200 or disconnected from the measurement device 200,it may be configured to automatically power off after a predeterminedamount of time if no button 1315 is actuated and no measurement device200 is connected or disconnected from the connector 1305. In someembodiments, the handheld device 1300 may be configured to automaticallypower off when the measurement device 200 is disconnected from theconnector 1305. In some embodiments, the predetermined amount of timebefore the automatic power off or power on may be user adjustable. Forexample, the predetermined amount of time may be set to five minutesbefore the user adjusts it to a larger or smaller amount of time. Insome embodiments, the handheld device 1300 may be configured toautomatically power on when the button 1315 is actuated even when nomeasurement device 200 is connected to the handheld device 1300. In suchan instance, the handheld device 1300 may be configured to displayinformation associated with the most recently connected measurementdevice 200. In some embodiments, once automatically powered on, the usermay be able to cycle through the various fields and parameters of thehandheld device 1300 by actuating the button 1315.

In some embodiments, the handheld device 1300 may comprise a memory thatmay be configured to store or save information read from one or morepreviously connected measurement devices 200. In some embodiments, whena new measurement device 200 is connected to the handheld device 1300,the information read from the new measurement device 200 mayautomatically replace the stored information in the memory. When thehandheld device 1300 is powered on when no measurement device 200 isconnected, the screen 1310 and the button 1315 may be used by the userto browse information for any measurement device 200 stored in thememory of the handheld device 1300. In some embodiments, the memory ofthe handheld device 1300 may be used to store information entered by theuser in relation to the measurement device 200, for example the name ofthe measurement device 200 or the location or point of installation ofthe measurement device 200.

In some embodiments, the handheld device 1300 may be designed to providea user with a device providing the ability to individually monitor aplurality of measurement devices 200 at the point of installation of themeasurement devices 200. The portable nature of the handheld device 1300may prevent damage of the measurement device 200 that may be caused byuninstalling or installing the measurement device 200 at its point ofuse. Additionally, the handheld device 1300 may minimize errors that maybe inherent in collecting a plurality of measurement devices 200 frommultiple points of installation and monitoring them at a centralizedlocation, for example, reinstalling the measurement devices at wrongpoints of use, mixing up the measurement devices while monitoringinformation from them, etc. For example, the handheld device 1300 mayreceive and display information comprising identification information ofthe measurement device 200. Alternatively, or additionally, the handhelddevice 1300 may receive and display the sterilization cycle count of themeasurement device or the location of installation of the measurementdevice 200. The handheld device 1300 may receive and display one or morecalibration parameters of the measurement device 200, one or moremanufacturing data of the measurement device 200, and/or customerspecific information of the measurement device.

The handheld device 1300 may provide instant, pushbutton access tointernal memory of measurement devices 200 to allow for quick inspectionby the user of the measurement device 200's sterilization cycle count,calibration status, battery life, and usage information. The handhelddevice 1300 may allow the user to access all information useful insynchronizing the measurement device to an external and autonomoussystem or integrating advanced or new measurement devices with existingcontrol systems without needing to upgrade or replace existing controlsystem equipment. For example, a large biopharmaceutical company mayhave an existing array of bioreactor control systems and equipment, forexample, having 100 pH meters, all of the control systems and equipmentbeing in good working order. The control systems and equipment mayrepresent a large investment. However, one or more of the bioreactorcontrol systems or other equipment may not be fully compatible with themeasurement devices 200 that store digital information in internalmemory and, thus, may be unable to make use of the additionalfunctionality of the measurement devices 200. Accordingly, specializedequipment or proprietary software may be required by the bioreactorcontrol systems or other equipment to communicate with and fullyintegrate and make use of the measurement devices 200 in the existingbioreactor control systems and equipment. Thus, accessing informationfrom the measurement device 200 and controlling the measurement device200 using the existing control systems and equipment may be inefficientand troublesome. Additionally, updating the control systems andequipment may be unrealistic and a wasted cost.

Instead of updating the control systems and equipment, the handhelddevice 1300 may be used to integrate the measurement device 200 with usewith existing control system and equipment. The handheld device 1300 mayallow users with an existing infrastructure to take advantage ofadditional functionalities of the measurement devices 200 (for example,having memory for storage of digital, operational information) withouthaving to invest substantial amounts in new control systems orequipment. The handheld device 1300 may provide an inexpensive andself-sufficient device that does not require any separate computingdevice, software, or application to communicate with and readinformation from the measurement devices 200. The handheld device 1300may be designed to interface directly with the measurement device 200and display the stored information in an intuitive and convenientmanner. Thus, the handheld device 1300 may allow the user to utilize theadditional functionalities of the measurement device 200 while theexisting control system and equipment may interface with and utilize themeasurement data and other previously existing functionalities of themeasurement device 200. Additionally, another example of a benefit ofthe handheld device 1300 may include the ability to determine amisplaced measurement device 200 where its history or use is unknown. Anadditional example of a benefit may be the ability read or writeinformation to the measurement device 200 without removing themeasurement device 200 from its position of use in the autonomoussystem.

The handheld device 1300 and the measurement device 200 may form asystem configured to provide the user with the heat sterilization cyclecount of the measurement device 200. In some embodiments, the user mayconnect a computing device to the handheld device 1300 and calibrate themeasurement device 200 connected to the handheld device 1300, view andedit information stored in the measurement device 200, and view and editinformation stored in the handheld device 1300.

The various operations and methods described above may be performed byany suitable means capable of performing the operations, such as varioushardware and/or software component(s), circuits, and/or module(s).Generally, any operations illustrated in the Figures may be performed bycorresponding functional means capable of performing the operations.

Information and signals may be represented using any of a variety ofdifferent technologies and techniques. For example, data, instructions,commands, information, signals, bits, symbols, and chips that may bereferenced throughout the above description may be represented byvoltages, currents, electromagnetic waves, magnetic fields or particles,optical fields or particles, or any combination thereof.

The various illustrative logical blocks, modules, circuits, andalgorithm steps described in connection with the embodiments disclosedherein may be implemented as electronic hardware, computer software, orcombinations of both. To clearly illustrate this interchangeability ofhardware and software, various illustrative components, blocks, modules,circuits, and steps have been described above generally in terms oftheir functionality. Whether such functionality is implemented ashardware or software depends upon the particular application and designconstraints imposed on the overall system. The described functionalitymay be implemented in varying ways for each particular application, butsuch implementation decisions should not be interpreted as causing adeparture from the scope of the embodiments of the invention.

For purposes of summarizing the disclosure, certain aspects, advantagesand features have been described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, the invention may be embodied or carriedout in a manner that achieves or optimizes one advantage or group ofadvantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

While this invention has been described in connection with what is arepresently considered to be practical embodiments, it will be appreciatedby those skilled in the art that various modifications and changes maybe made without departing from the scope of the present disclosure. Itwill also be appreciated by those of skill in the art that parts mixedwith one embodiment are interchangeable with other embodiments; one ormore parts from a depicted embodiment can be included with otherdepicted embodiments in any combination. For example, any of the variouscomponents described herein and/or depicted in the Figures may becombined, interchanged or excluded from other embodiments. With respectto the use of substantially any plural and/or singular terms herein,those having skill in the art can translate from the plural to thesingular and/or from the singular to the plural as is appropriate to thecontext and/or application. The various singular/plural permutations maybe expressly set forth herein for sake of clarity. Thus, while thepresent disclosure has described certain exemplary embodiments, it is tobe understood that the invention is not limited to the disclosedembodiments, but, on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the scope ofthe appended claims, and equivalents thereof.

What is claimed is:
 1. A system, comprising: a measurement deviceadapted to withstand and automatically count a heat sterilization orcleaning cycle, comprising: a measurement probe comprising a sensorconfigured to detect a characteristic of a medium and generate ameasurement signal; a condition responsive element comprising either atemperature responsive element or a pressure responsive element; and aheat cycle detection unit comprising a detection module, a datainterface, and a data memory; wherein the detection module is configuredto: detect a heat cycle event using the condition responsive element,and record detection of the heat cycle event in the data memory, whereinthe measurement device is configured to automatically power off the heatcycle detection unit after detection of the heat cycle; and a handhelddevice connected to the measurement device, the handheld devicecomprising: a screen; a button; a communication circuit configured tocommunicate with the measurement device and a computing device; and aprocessing system configured to receive non-measurement information fromthe measurement device, display the received information on the screen,and cycle the received information displayed on the screen based on anactuation of the button, wherein the handheld device is used to displaya heat cycle event count of the measurement device.
 2. The system ofclaim 1, wherein the handheld device may communicate with the computingdevice and be configured to perform at least one of calibrating themeasurement device via the computing device, viewing information storedin the measurement device via the computing device, editing informationstored in the measurement device via the computing device, viewinginformation stored in the handheld device via the computing device, andediting information stored in the handheld device via the computingdevice.
 3. The system of claim 1, wherein the handheld device is furtherused to display one or more of calibration parameters of the measurementdevice, manufacturing data of the measurement device, and customercustom fields of the measurement device.
 4. The system of claim 1,wherein the handheld device further comprises a battery or an externalpower source, wherein the battery or external power source is configuredto provide electrical power to the screen, the processing system, andthe measurement device.
 5. The system of claim 4, wherein the externalpower source comprises an inductive or other wireless power sourceconfigured to wirelessly transfer power to at least one of the handhelddevice and the measurement device.
 6. The system of claim 1, wherein thehandheld device further comprises a memory configured to store theinformation received from the measurement device and information enteredby a user via the button or the computing device.
 7. The system of claim1, wherein the information received by the handheld device from themeasurement device comprises one or more of an identificationinformation of the measurement device, a heat cycle event count of themeasurement device, a location of installation of the measurementdevice, one or more calibration parameters of the measurement device,one or more manufacturing data of the measurement device, and customerspecific information of the measurement device.
 8. The system of claim7, wherein the one or more manufacturing data comprises a serial number,a manufacturer part number, performance data, and a date of calibrationand performance tests.
 9. The system of claim 7, wherein the customerspecific information comprises an experiment name with which themeasurement device is associated, an operator's name with which themeasurement device is associated, a lot number with which themeasurement device is associated, and one or more customer definedfields.
 10. The system of claim 1, wherein the handheld device isfurther configured to receive data measured by the measurement device.11. The system of claim 1, wherein the handheld device further comprisesone or more connectors via which communications with one or more of themeasurement device and the computing device are enabled, wherein the oneor more connectors allow for physical and electrical connections betweenthe handheld device and the one or more of the measurement device andthe computing device.
 12. The system of claim 1, wherein the measurementdevice is configured to automatically power on the heat cycle detectionunit at the beginning of the heat cycle in response to a change of stateof the condition responsive element.
 13. The system of claim 1, whereinthe measurement device further comprises a physical, optical, inductive,and/or wireless coupling connector, and wherein said physical, optical,inductive, and/or wireless coupling connector is configured to permittransfer of at least one of energy, power, and data via physical,optical, inductive and/or wireless coupling between the measurementdevice and at least one of an external power supply or transmitter. 14.The system of claim 1, wherein the handheld device is reversiblyconnected to the measurement device.
 15. The system of claim 14, whereinthe reversible connection is a physical, optical, inductive, and/orwireless connection.
 16. A method of automatically counting anddisplaying a heat cycle experienced by a measurement device, comprising:detecting a heat cycle event experienced by the measurement device usinga condition responsive element, the measurement device comprising: ameasurement probe having a sensor configured to detect a characteristicof a medium and generate a measurement signal, a heat cycle detectionunit having a detection module, a data interface, and a data memory, andthe condition responsive element; recording detection of the heat cycleevent in the data memory; communicating information to a handheld devicevia a reversible physical, optical, inductive, and/or wirelessconnection between the measurement device and the handheld device; anddisplaying the information from the measurement device on a screen ofthe handheld device, wherein the information displayed comprises atleast one of a heat cycle event count of the measurement device and oneor more identifying information or calibration parameters of themeasurement device.
 17. The method of claim 16, wherein the measurementdevice is configured to automatically power on the heat cycle detectionunit at the beginning of the heat cycle in response to a change of stateof the condition responsive element or automatically power off the heatcycle detection unit at the beginning of the heat cycle after detectionof the heat cycle event.
 18. The method of claim 16, wherein themeasurement device comprises a battery and a capacitor, the methodfurther comprising charging the capacitor from the battery when themeasurement device automatically powers on, automatically powering offthe heat cycle detection unit when the capacitor is charged, anddischarging the capacitor when the condition responsive elementindicates the heat cycle event is substantially complete.
 19. The methodof claim 16, wherein the condition responsive element is a first switchthat transitions from a first state to a second state when the firstswitch exceeds a first temperature or a first pressure, and thedetection module records detection of a heat cycle event in the datamemory in response to the first switch transitioning from the firststate to the second state.
 20. The method of claim 16, wherein themeasurement device further comprises a second condition responsiveelement, wherein said second condition responsive element is a secondswitch configured to transition from a power-on state to a power-offstate when the second switch reaches a power-off temperature orpressure, and wherein the heat cycle detection unit automatically poweroffs when the second switch transitions from the power-on state to thepower-off state.
 21. The method of claim 16, wherein the detectionmodule detects a heat cycle event and records detection of the heatcycle event in the data memory in response to either a proximalcondition responsive element exceeding a first temperature or firstpressure or a distal condition responsive element exceeding a vesselsterilization temperature or pressure.
 22. The method of claim 16,wherein detecting a heat cycle event and recording detection of the heatcycle event in the data memory comprises: detecting an autoclave cycleand recording detection of the autoclave cycle in the data memory inresponse to a proximal condition responsive element exceeding a firsttemperature or a first pressure, and detecting a steam-in-place cycleand recording detection of the steam-in-place cycle in the data memoryin response to a distal condition responsive element exceeding a vesselsterilization temperature or pressure and the proximal conditionresponsive element not exceeding the first temperature or the firstpressure.